ML20148P214
| ML20148P214 | |
| Person / Time | |
|---|---|
| Issue date: | 06/13/1996 |
| From: | Sobel P NRC |
| To: | Trottier C NRC |
| Shared Package | |
| ML20148P089 | List: |
| References | |
| FRN-61FR65120, RULE-PR-20 AF31-2-045, AF31-2-45, NUDOCS 9707020030 | |
| Download: ML20148P214 (92) | |
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NOTE TO: 'CO Trottieri FROM: P. Sobel l g Attached are the Divisio of W ste Management's editorial and minor technical comments on the draft Commission paper on the final constraint rule for air emissions. Earlier I provided you NRR's comments. IMNS provided their comments.to-you separately. The official NMSS concurrence letter will be from '
Carl Paperiello to David Morrisc 1 cc: R. Nelson (w/o Attachment)
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k i FOR: The Commissioners FROM: James M. Taylor, Executive Director for Operations ;
SUBJECT:
FINAL RULEMAKING - REVISION TO 10 CFR PART 20 RELATED TO ,
CONSTRAINT FOR AIR EMISSIONS FROM NRC AND AGREEMENT STATE LICENSEES OTHER THAN POWER REACTORS l
PURPOSE:
- To request Commission. approval to publish a notice of final rulemaking ,
amending the regulations in 10 CFR Parts 20. !
i BACKGROUND:
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h On November 15, 1995, the Commission directed the staff to publish a proposed rule amending 10 CFR Part 20, establishing a constraint of 10 mrem /yr total effective dose equivalent (TEDE) for dose to members of the public from air _.
emissions of radionuclides from NRC licensed facilities other than power i reactors. A proposed rule was published in the Federal Register (60 FR 63984) '
on December 13, 1995, amending 10 CFR Part 20 to include a constraint on air i emissions.
The proposed rule specified that to implement the as low as is reasonably achievable (ALARA) requirements of Part 20, licensees other than power reactors would be required to report to NRC, air emissions that by calculation or measurement, resulted in a dose to a member of the 3ublic in excess of 10 mrem in any year. In addition, t licensee would >e required to propose l corrective actions adequate to ensu against future air emissions leading to !
n doses.in excess of the constraint. The proposed rule exempted emissions of e radon-222 from consideration.
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' CONTACT:
Charleen T. Raddatz,.RES hMreM /V[. ;
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'd j The Commissioners 2 DISCUSSION:
Fifty-seven comment letters were received on the proposed rule. among the 57 letters, 24 were licensees, 7 professional organizations, 5 Sta.es, 16 members of the public, ano 5 environmental organizations.
In general, those persons expressing the view that the proposed constraint was too restrict've, too burdensome, and unnecessary were licensee mbers of the public and professional societies. In general, those perst pressing $ /
the view that the proposed constraint was too lax, inadequate protect the health of the public, and not adequately enforceable were representatives of environmental groups.
The final rule is basically unchanged from the proposed rule. However, in resolving public comments, a few minor changes were made in the final rule.
The staff removed the requirement to report demographic information on exposed members of the public, as the information may not be available to licensees and is not needed by NRC for any purpose. A provision defining the effective date of the rule has been added to ensure that there is not a time when both NRC's and EPA's rule would be in effect. The rule has been revised to clarify h that the constraint is intended to only apply to environmental air emissions' p n This is needed to more closely parallel the existing requirements of /-
l ) Subpart I. In addition, the regulatory cuida will be revised to address s n / % ed T S i public comments. q-of considerations for the final rule addresses other comments
--- by The statement clarifying [the purpose of the rule. that if a licensee exceeds It states the constraint p ports't'o NRC, and takes corrective actions as agreed upon that exceedence in subsequent years would not be violations. Rather,thehNC#hstig would (gain be required to report and take appropriate corrective actions.
RESOURCES:
4 The current budget contains resources to conduct the inspection and enforcement n u icens programs to control air emissions in accordance with additional resources will be required to implement the g /, ( p xisting rules provisions of the fin rule. '
COORDINATION:
The Office of the General Counsel has no legal objection to this paper.
RECOMMENDATION:
That the Commission:
The Commissioners 3 (O) .
- 1. Approve publication of the final rule.
- 2. Certify that the final rule will not have a negative economic impact on a substantial number of small entities, in order to satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
Note:
- a. The final rule (Attachment 1) will be published in the Federal Register; i b. A Regulatory Analysis has been prepared and will be made available in the Public Document Room (Attachment 2);
- c. The staff has determined that, under the Small Business Regulatory Enforcement Fairness Act of 1996, this is not a major rule because licensees affected by this rule are currently subject to the more burdensome requirements of 40 CFR 61, Subpart I, that it replaces.
Appropriate notification will be made (Attachnent 3);
- d. An environmental assessment and finding of no significant impact
- p. has been prepared and will be made available in the Public
, Document hoom (Attachment 4);
'e. accordance with the Regulatory Flexibility Act, a regulatory flexibility analysis has been prepared. The analysis /
is not a separate document but part of the Federal Register
, notice. The analysis indicates that the economic impact on licensees and small entities will not be significant. The analysis will be made available in the Public Document Room and a copy will be sent to the Chief Counsel for Advocacy of the Small Business Administration. .
- f. The final rule contains new information collection requirements y and, therefore, is subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The staff is preparing a Federal Register notice forMPsubmittalgefore publication of the final rule; gA
- g. A public announcement will be issued (Attachment 5);
, h. The appropriate Congressional committees will be informed (Attachment 6); and
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The Commissioners '4
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. i. Copies of the Federal Register notice of final rulemaking will. be i distributed to all: licensees. The notice will be sent to other !
interested parties upon request.
i James M. Taylor i Executive Director for Operations '
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- Attachments: As stated (6) i d
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' i. Copies of the Federal Register notice of final rulemaking will be distributed to all licensees. The notice will be sent to other interested parties upon request.
James M. Taylor Executive Director for Operations Attachments: As stated (6) l 1
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RECORD NOTE: A DRAFT COPY OF THE FINAL RULE WAS SENT TO OIG FOR INFORMATION ON , 1996.
. Distribution:
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NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 RIN 3150-AF31 ;
Resolution of Dual Regulation of Airborne Emissions, ?
Clean Air Act !
i AGENCY: Nuclear Regulatory Commission.
ACTION:- Final rule.
SUMMARY
- The' Nuclear Regulatory Commission is amending its regulations to establish a constraint of 10 mrem /yr total effective dose equivalent '(TEDE)
'for dose to members of the public from air emissions of radionuclides from NRC licensed facilities other than power reactors. 'This action is necessary.to provide assurance to the Environmental Protection Agency (EPA) that future
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, emissions from NRC licensees will not exceed dose levels that will. provide an ample margin of safety. This action is expected to be the final step in providing EPA with a basis upon which to rescind its Clean Air Act (CAA) regulations for.NRC licensed facilities (other than power reactors) and
,' Agreement State licensees, thereby relieving these licensees from unnecessary dual regulations.-
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H Final Constraint Rule- 1 May 10,.1996
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if EFFECTIVE DATE: This rule will become effective on the date of publication in U
the Federal Register of the rescission of 40 CFR 61, Subpart I by EPA.
FOR FURTHER INFORMATION CONTACT: Charleen T. Raddatz, Office of Nuclear i Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6215.
SUPPLEMENTARY INFORMATION:
Background
The EPA promulgated National Emission Standards for Hazardous Air Pollutants (NESHAPs) for radionuclides on October 31, 1989. Subpart I of D 40 CFR 61 was promulgated to implement the CAA and limit doses to members of the public from air emissions of radionuclides (other than Radon-222) from all NRC licensees other than licensees possessing only sealed sources, high-level i waste repositories and uranium mill tailings piles that have been disposed of in accordance with 40 CFR Part 192,and-are strtrfect to ne requirmnis of --
/ N zm h ithU vc Radon-222 emiss ns from tailings were covered by N
CFR 61, hbparts T and 4.%u (c
S rt T was rescinded for NRC licensees after /[
Appendix A to Part 40 was amended by the Commission to conform to changes EPA
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. issuedto40CFR'192thatadoptedtheprovisionsofSubpartI ubpart W still applies to NRC licensee . Because Radon-222 is adequately addressed in ,
Appendix A to Part 40 and other provisions of Part 20 1t is not covered in 3
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' Final Constraint Rule '2 May 10, 1996
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) Under Subpart I, emissions of radionuclides must be limited so that no member of the public would receive an effective dose equivalent of greater than 10 mrem /yr'.
In 1990, Congress enacted amendments to the CAA. Section ll2(d)(9) of these amendments to the CAA (the Simpson amendment) states: ,_
No standard for radionuclide emissions from any category or subcategory of facilities licensed by the Nuclear Regulatory Commission (or an Agreement State) is required to be promulgated under this section if the Administrator determines, by rule, and after consultation with the Nuclear Regulatory Commission, that the regulatory program established l 1
by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act j for such category or subcategory provides an ample margin of safety to o
protect the public health.
Upon issuance, the effectiveness of Subpart I for all NRC licensees was immediately stayed by EPA pending further evaluation. During the stay period, EPA conducted two studies of the air emissions from NRC and Agreement State materials licensees. The first was a survey of 367 randomly selected nuclear materials licensees. EPA determined that the highest estimated dose to a 1
member of the public from air emissions from these facilities was 8 mrem /yr, l based on very conservative modeling. In addition, 98 percent of the 1
Subpart I expresses dose in effective dose equivalent (EDE). NRC ex esses dose in total effective dose equivalent (TEDE). These terms are
,_s essentially equivalent. For the sake of consistency, this paper will refer to l
/ T all doses in terms of TEDE.
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( ) facilities surveyed reported doses to members of the public resulting from air emissions--less than 1 mrem /yr. The second study evaluated do e9 rom air 4 emissions- from 43 additional facilities that were selected because of their potential for air emissions resulting in significant public exposures. EPA
[ found that 75 percent of these licensees had air emissions resulting in an ._
estimated maximum public dose less than 1 mrem /yr. For the licensees 3 evaluated, none exceeded 10 mrem /yr.
In its initial proposal to rescind Subpart I for NRC licensees other than power reactors, EPA stated that:
BasedontheresuhfthesurveyundertakenbyEPAandthecommitments made by NRC in the M00, EPA has' made an initial determination that the NRC program under the Atomic Energy Act provides an ample margin of safety to protect the public health (57 FR 56880; December 1,1992).
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However, EPA continued to express concern regarding the adequacy of the measures to " assure EPA that future emissions from NRC licensees will not exceed levels that will provide an amp's margin of safety." The stay on Subpart I expired on November 15, 1992, and Subpart I became effective on November 16, 1992. Subsequently, in July of 1993, the EPA Administrator !
determined that there was insufficient basis at that time to rescind Subpart I. Consequently, NRC and Agreement State licensed facilities were subject to dual regulation of air emissions of radionuclides under both the AEA and the'CAA, including regulatory oversight by EPA (or authorized State) I and NRC-(or Agreement State).
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u Final Constraint Rule 4 May 10, 1996 l
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NRC licensees subject to Subpart I are also subject to NRC dose limits
-(v) for members'of the public contained in 10 CFR Part 20, Subpart D entitled
- Radiation Dose 1.imits for Individual Members of the Public" (Subpart D).
Under Subpart D, licensees shall ensure that doses to members of the public are less than 100 mrem /yr from all pathways (including air emissions) and all sources associated with the licensee's operation. In addition, doses to members.of the public must be kept as low as is reasonably achievable (ALARA).
Based on the aforementioned studies conducted by EPA and licensee reporting of ,
l doses to members of the public from air emissions to EPA, it is evident that less than 10 mrem /yr to the maximally exposed member of the public from air emissions is reasonably achievable.
NRC power reactor licensees subject to 10 CFR 50.34a must keep doses to members of the public from air emissions consistent with the numerical
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guidelines in Appendix I to 10 CFR Part 50. In addition, these licensees have Q.-l for many years reported estimated doses to members of the public from air emissions well below the Subpart I value. Based on the combination of a continuing regulatory basis for reduced air emissions and documented proof of the effectiveness of the NRC program for these licensees, EPA has already rescinded Subpart I for power reactors licensed by NRC (60 FR 37196; September 5, 1995).
Amendments The amendments proposed on December 13, 1995 (60 FR 63984), and finalized herein, establish a constraint of 10 mrem /yr TEDE for do o members of the public from air emissions of radionuclides from NRC licensed
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Final Constraint Rule 5 May 10, 1996
( - facilities other than power reactors as a part of its program to maintain v
' doses ALARA.~ The amendments codify numerical values for NRC's application of -
ALARA guidelines on radioactive air emissions from its licensees, other than power reactors. For power reactors, ALARA guidelines have already been j established within 10 CFR Part 50 and facility licensing conditions. The amendments ensure that air emissions are maintained at a very low evel and, #
taking into consideration the elimination of dual regulation, at little or no cost. This action brings consistency between EPA's dose standard and the NRC's ALARA application, thereby providing EPA with a basis upon which to rescind Subpart I as it applies to NRC licensed facilities other than power reactors.
This action'is expected to be the final step in providing EPA with a basis 1
upon which to rescind Subpart I for NRC licensees other than power reactors. ;
1 NRC has been working cooperatively with EPA over the last several years l to support rescission of EPA's standards in Subpart I of 40 CFR Part 61 in accordance with Section 112(d)(9) of the CAA. The fundamental objective of this effort is to eliminate unnecessary duplicative regulations that provide no incremental benefit in terms of public and environmental protection. ;
1 The regulatory framework within which NRC is providing a basis for I rescission of Subpart I consists of the requirements in 10 CFR Part 20 to limit doses to members of the public to 100 mrem /yr, to maintain these doses as far below this limit as is reasonably achievable (ALARA), and to constrain dosho members of the public from air emissions of radioactive materials from #
a single source to 10 mrem /yr.
The rule will require that if the licensee estimates or measures a dose to a member of the public expected to receive the highest dose from air
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Final Constraint Rule 6 May 10, 1996 i
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effluents to be less than'10 mrem /yr, the. licensee would be required to record the dose and the assumption used to calculate it, consistent with the requirements of 5 20.2103. This data would be made available to inspectors ,
upon request. If the licensee estimates or measures a dose to the member of the public expected to receive the highest dose from air effluents to be greater than 10 mrem /yr, the licensee would be required to report the dose to-NRC in writing within 30 days. In addition, the licensee would be required to include in that report the circumstances that led to the greater than 10 ,
mrem / year dose, a description of the corrective steps the licensee had taken or proposed to take to ensure that the constraint is not again exceeded, a
'l timetable for implementing the corrective steps, and the expected results.
The constraint on dose from air emissions is different than a limit. ] 1 Exceeding this constraint will not result in a Notice of Violation (N0V). j n
Rather, a NOV will be issued only upon failure to report that actual or /
k estimated dose from air effluent releases from a facility, have exceeded the constraint value'and/or failure to institute appropriate measures-to correct andpreventfurtheremissionsinexcessofthosewhichwouldresultindo@
exceeding the constraint level. - 7j ge e'b.7 1 The rule will apply to airborne releases, other than Radon-222 and_ <t f !
daughters,fromallNRClicenseesexceptpowerreactok reactors are exempt from this proposed rule because they are already required under 10 CFR .
50.34a to identify', in their application, design objectives and the means to
.be employed for keeping doses to members of the public from air effluents ALARA. - Appendix I;to Part 50 contains the numerical guidelines to meet this i requirement.
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Final Constraint Rule 7 May'10, 1996 l
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) Response to Comments fifty-seven individuals and organizations provided written comments on the proposed rule and the regulatory guide. Among the 57 comments, 24 were licensees, 7 professional organizations, 5 States,16 members of the public, and 5 environmental organizations. Sincemanyletterser'commendnthe
_( %bh rl subject of4he regulatory guid'e ' cluded comments on the rule, they were also -[
considered in developing the final rule.
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Issue 1 - PROPOSED RULE APPROACH Comments: A total of thirty-one individuals and organizations commented j
on the basis for the rule. Five commenters agreed with the approach and need for the constraint. Four commented that the rule should not be finalized and 7
I ) Subpart I should remain in effect. Twenty-two commenters stated that existing NRC programs provided an ample margin of safety and that the constraint was not needed. However, of these, seven agreed that the constraint was preferable to dual regulation or Subpart I alone.
Those commenting that existing NRC programs are adequate to protect the public cited the EPA studies on doses from air emissions. Two-thirds of these commenters were opposed to going forward with the constraint as it was not needed r.nd costs could not be justified given the expectation that risk would not be reduced. These commenters encouraged NRC to continue working with EPA to provide sufficient basis for rescission of Subpart I without the imposition of an equally unnecessary regulation. A few stated that the risk was considerably less than estimated as excessively conservative calculational
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J Final Constraint Rule 8 May 10, 1996
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! )-_ methods were used by EPA. A few compared the 10 mrem /y constraint to variability in background or doses from commercial air traffic as evidence that the dose, and the risk, is trivial. Of the seven agreeing that the constraint was preferable to dual regulation or EPA's Subpart I alone, burden reduction and single-agency oversight were the reasons cited.
Commenters opposed to the constraint as a less protective standard, stated that the constraint was based upon a voluntary program (ALARA) and as such was not adequate to protect the public. One commenter stated that NRC does not do confirmatory measurements and therefore NRC jurisdiction was not adequate.
Response: NRC and EPA have been working cooperatively to develop a basis upon which dual regulation could be eliminated. EPA has stated that there are two necessary components to any finding that NRC's program is (q) v sufficient to protect the health and safety of the public. The first is l
evidence that doses from air emissions are below 10 mrem /y to a member of the public. This has been demonstrated through the two studies undertaken by EPA and by licensee reporting of actual air emissions. The second component is a program to ensure that doses remain at this low level. In the absence of rulemaking requiring licensees to maintain doses to levels of no more than 10 mrem /y, EPA would not rescind Subpart I, and dual regulation would continue.
The Federal Radiation Council (FRC) was formed in 1959 to provide recommendations to the President for Federal policy on radiation matters affecting health. In May of 1960, FRC set forth basic principles for protection of both workers and members of the public. The council was
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( abolished in 1970 and its functions transferred to the Administrator of the !
" newly formed Environmental Protection Agency. In 1981, EPA published proposed j recommendations' for new Federal guidance for occupational exposure. In 1987, President Reagan approved recommendations by the Administrator of EPA for new !
" Radiation Protection Guidance to Federal Agencies for Occupational Exposure." !
1 EPA has not yet issued recommendations on limits for members of the public. A l working group comprised of representatives of affected Federal Agencies and experts has been developing these recommendations for several years. It is ' l expected that they will do so within the next year.
The International Council on Radiological Protection (ICRP) issued its Report No. 26 " Recommendations of the International Council on Radiological Protection" in 1977. These recommendations included that the average doses to i
. members of the public should not exceed 100 mrem /yr with a limit of 500 i
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- \,] mrem /yr to any individual. l The National Council on Radiation Protection and Measurements (NCRP) has 1 the responsibility under its charter from the Congress of the United States to recommend limits for exposure te ionizing radiation. In June of 1987, NCRP ,
issued its Report No. 91 " Recommendations on Limits for Exposure to Ionizing Radiation." This report makes recommendations on limits for both i
occupationally exposed individuals, and individual members of the public. The report recommended that doses to individual members of the public be limited ,
tc 100 mrem /y averaged over a lifetime, not to exceed 500 mrem in any one year. ,
- O Final Constraint Rule 10 May 10, 1996 I
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(v ) In 1991 NRC revised its 10 CFR Part 20 " Standards for Protection Against Radiation." This revision included new limits for individual members of the public. Though both the ICRP and the NCRP recommended limits of 500 mrem in any one year, the NRC established a limit of 100 mrem /yr as it was deemed to be impractical to control dose in terms of lifetime average without keeping track of individual exposures. In addition, Part 20 requires that licensees use procedures and engineering controls to maintain doses as low as is reasonably achievable (ALARA).
Both the NRC and EPA regulatory programs are designed to achieve the goals presented in the Federal guidance, ICRP recommendations, and NCRP recommendations. The approaches of the two agencies differ. NRC limits TEDE and requires that doses are maintained ALARA. EPA limits dose from individual l 1
pathways of exposure and individual radionuclides to ensure that the total
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) dose does not exceed the recommended levels. Both programs achieve similar i levels of protection.
I NRC agrees that adoption of the constraint in 5 20.1101(d) is preferable to dual regulation or regulation under 40 CFR 61, Subpart I alone due to the reduction in burden on licensees as well as State and Federal Government agencies. Under the provisions of 40 CFR 61, licensees with doses to members of the public greater than 1 mrem /y but less than 10 mrem /y have to submit reports, recommend and implement corrective actions pursuant to Subpart I.
These reporting-requirements, even for licensees who have not exceeded any limit, are necessary under Subpart I as EPA does not perform routine inspections to ensure compliance with their regulations. However, under
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Final Constraint Rule 11 May 10, 1996
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( ) i 20.1101(d), these licensees will not have to file reports for doses u-below the constraint level. The reason this is not necessary, is that doses can be evaluated at the time of routine inspections performed by trained inspectors. Under the new regime, the burden of calculating doses should be reduced for most licensees because the proposed guidance for demonstrating ,
compliance with 5 20.1101(d) allows significantly more flexibility and simpler methods for calculating doses than does the COMPLY model currently used to i
implement 40 CFR 61. These new methods for calculating doses should result in fewer reporting and corrective actions.
The Federal and State Government burden should be duced as "
the number of annual reports requiring review and follow up actions should decline from several hundred per year to at most a few. Because NRC inspectors are already inspecting records of air emissions, there is little
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( v ) additional burden to NRC as a result of the promulgation of this rule. There 1
is the one time burden for promulgation of the rule, rescission of Subpart I and development of regulatory guidance and inspection procedures. There is also a one time burden for implementation of compatible regulations by Agreement States. Overall, the burden to State and Federal agencies shculgbe reduced. I The NRC inspection program does not routinely include confirmatory :
measurements, but air effluent records are routinely inspected by NRC and confirmatory measurements are performed if it is deemed necessary by the inspector. Further, as previously stated, confirmatory measurements are not l currently performed to ensure compliance with Subpart I. j (J ) I Final Constraint Rule 12 May 10, 1996
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/ s-(v) Finally, concerning those commenters that believe NRC's requirements dAu p.
less safe than Subpart I, in 1990, Congress enacted legislation s
comprehensively amending the Clean Air Act (CAA), which included a section ,
addressing the issue of. regulatory duplication between EPA and NRC. The 1990 CAA amendments permit the Administrator of EPA to rescind the CAA standards as l
they apply to radionuclides,' at sites licensed by NRC and the Agreement States, if she finds that the NRC regulatory program provides an ample margin _
of safety to protect the public health.
EPA's analysis of the NRC regulatory program focused on two general issues: (1) whether the implementation of the NRC regulatory program results in sufficiently low doses;to protect the health and safety of the public with ,
an ample margin of safety, and (2) whether the NRC program is sufficiently comprehensive and thorough, and administered in a manner that will continue to !
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( protect public health in the future. EPA undertook studies to determine the level of protection provided by the existing regulatory program and found that )
doses were sufficiently low to protect the health and safety of the public with an ample margin of safety. The implementation of this rule will ensure that doses to members of the public, from air effluents, will continue to remain below 10 mrem /y and thereby provide evidence to EPA that the currently existing level of protection will continue to be afforded into the future.
The purpose of this rulemaking is therefore not to reduce doses, as it has already been demonstrated that doses are sufficiently low. Rather, the primary purpose is to reduce costs associated with'the level of protection
- currently afforded, by providing a basis upon which EPA can find that doses will not increase as a result of rescission of Subpart I. Secondarily, the io\
V Final Constraint Rule 13 May 10, 1996 i
(. ) rule will . ensure that doses are maintained at the low level currently achieved
-by NRC-licensees. -
, Issue 2 - PROMULGATION OF THE CONSTRAINT AS ALARA .
Comments: There were a number of commenters who. objected to the ALARA basis for the proposed constraint rule. Some objected on the ground that ;
ALARA is a matter of operating philosophy, good radiation protection practice and licensee judgment, and cannot be translated into an enforceable dose number. Others objected that ALARA is inherently site specific and # I cannot be defined generically, or that the proposed dose constraint cannot be !
J ALARA but must instead be a limit because the constraint contemplates some J enforcement-actions for exceedance even if the licensee has followed all good
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\J radiation protection practices. Finally, some argued that the rule cannot be
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ALARA because it adds costs with no safety benefit y and others stated that the -
constraintisinconsistentwithapriorNRCdecisionon"referencelevels.g l Response: The Commission has retained an ALARA basis for the rule but i
recognizes that its use of the term in this rule may have led to some confusion. The Commission acknowledges that the ALARA concept in 20 CFR 20.1003, is an operating philosophy which requires good radiation protection practice and.the exercise of licensee expert judgement.
What the NRC had in mind in the proposed constraint rule is a somewhat broader concept found in the governing statute, the Atomic Energy Act of 1954, as amended.("Act"). The Act, as construed by both the Commission (e.g. 10 CFR !
3 50.109) and the courts (Union of Concerned Scientists v. NRC, 824 F.2d 108 u
final Constraint Rule ~ 14 May 10,-1996
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) (D.C. Cir.1987), contemplates two distinct approaches to radiological a
regulation. First a level of " adequate protection" must be defined and enforced without regard to economic cost, and second risk may be reduced to a level below that associated with " adequate protection" to " minimize danger to life or property" with economic cost and other factors as permissible balancing considerations. See " Revision of Backfitting Process for Power Reactors," 53 Fed. Reg. 20603 (June 6, 1988). Of critical importance here, the Act provides the Commission with power to adopt and enforce generic requirements using either approach (Act 5 161b). Many recent NRC regulations (e.g.,10 CFR 50.63) have been directed at incremental risk reduction under the second approach based on a generic regulatory or backfit analysis which considered and balanced economic and other costs and safety backfits. These
" minimize danger" regulations provide " limits" in the sense that they
) establish generic requirements directly enforceable against licensees, but in a broad sense they are also ALARA regulations in that cost, feasibility and other relevant factors identified in 10 CFR 20.1003 are weighed and balanced.
Viewed in its larger statutory context, ALARA in 10 CFR 20.1003 is one means to implement the second approach to radiological regulation but other similar requirements can also be part of this second approach. In particular, while the ALARA concept in 10 CFR 20.1003 may not be consistent with a generic enforceable dose requirement, other concepts of ALARA premised on generic g7
$%Y.iderations cons are also legallv normissible. This broader concept of ALARA V a broadly applicable dose requirement based on a generic weighing and balancing of health and safety, feasibility, and other factors - is the basis for the longstanding limits on nuclear power reactor emissions in 10 CFR
)
Final Constraint Rule 15 May 10, 1996
4
. i p
Part 50, Appendix I, and is the basis for the constraint rule. This kind of ALARA rule imposes a limit in the sense that exceedance will lead to enforcement action to achieve compliance, but it is not a limit in the sense that conformance is needed for adequate protection.
Thus, to say.that the constraint rule cannot be based on ALARA because
/
it is in effect a " limit" ',--
R ..f. interchannat a narrow concept of 7 ;
"ALARA" with a broad concept of " limit." If a broad definition is used the /
constraint rule withstands scrutiny as both ALARA and a limit. In particular, 1
in the statutory context of the Atomic Energy Act and general principles of administrative law, the constraint rule is a limit based on generic ALARA -l l
considerations. The constraint. rule is not a limit needed for adequate protection, and is something more than a narrow translation of the particular ALARA concept in 10 CFR 20.1003. Solely to avoid confusion with the narrow l CT . concepts of ALARA and limit often employed in radiation protection discussion, /
I the term " constraint" was used for the rule r ". ..... R iui..un.
This leaves three matters to be addressed - the comment that the rule cannot be based on ALARA because it will result in increased cost with no safety benefit, the problem of the licensee who cannot meet the dose 1
constraint despite using all good radiation protection practices, and the allegedly inconsistent Commission discussion of reference levels in a recent revision to 10 CFR Part 20. The Commission disagrees with the premise of the l
first comment. There was no disagreement with the Commission's conclusion that all of the licenses affected by the rule are achieving a level of control such that doshre.below the 10 mr evel and so there is no factual dispute -
over whether this level'of radiation protection is readily achievable. The im j
. w-) -
k l Final Constraint Rule 16 May 10, 1996
I ) rule itself, considered with EPA's rescission of its Clean Air Act emission limits and related requirements, will resul / a significant net cost savings #
to licensees. We_ acknowledge that, given the current level of controls, the positive direct health effects are likely to be small and possibly zero in the near future, but the rule will have the effect of preventing possible future backsliding by licensees, and so can be said to offer some small but positive net health and safety benefit. Under the broad ALARA concept described above, it is entirely appropriate to base a rule on a small positive health and safety benefit when cost savings are also likely.
We do not expect that any licensee subject to the rule will be unable to comply. In the unlikely event that, due to some temporary circumstances or lapse in controls, the dose level is or is projected to be exceeded, licensee (h h /
(
v) actions to come w&t4 ompliance are expected and, if needed, will be enforced. //
ven current information on the practicality of stringent
/-
{Me unforeseek controls, niikelycircumstanceofalicensee[beingunabletocomply,because /
of limits in the technology or exorbitant cost, can b ddressed in the ~
future on a case by case basis.
decs ne+ A ly .y Finally, this rule is not inconsistent with the enneen f reference level which was rejected by the Commission when Part 20 was recently revised.
Commenters on the 1991 revision to Part 20 objected to the use of reference levels as they were implemented exactly the same as limits. For that reason [
the Commission eliminated reference levels from the final 1991 revision.
F #
Implementation of the constraint is different than a limit in that exceedf ce
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-Final Constraint Rule 17 May 10, 1996
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V is not a violation, and it only requires licensee actio It is not th -
purpose of the constraint rule to provide such added assuranc regaweA by areferna Iwel 7 Issue 3 - WHETHER THE CONSTRAINT IS ACTUALLY A LIMIT Comments: Nine comments were received on whether the constraint is or should be a limit. . Two commented that the constraint was no different than a limit. One commenter agreed with the term constraint. Three commenters expressed concern that the constraint was an inappropriate relaxation of requirements.
Those commenting that the constraint was a de facto limit, interpreted the requirements to indicate that a second exceedynce of the constraint would result in enforcement action and therefore is a limit. Three commenters
/^\
indicated that the rule should be a strict limit. They expressed concern that (v) the constraint was less protective than Subpart I.
Response: A constraint is not the same as a limit. The constraint is a dose at which the licensee must notify NRC, but it is not a dose above which enforcement action would necessarily be taken. If a licensee exceeds a limit, the NRC may take immediate enforcement action. If a licensee exceeds a constraint, licensees will be required to notify NRC and implement corrective actions that are adequate to prevent further doses in excess of the constraint. In the unlikely event that calculations in the following year indicate that the constraint has again been exceeded, where agreed upon corrective actions had been appropriately implemented, enforcement action
('q,/
s )t Final Constraint Rule 18 May 10, 1996
h
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' O would not necessarily be considered. I owever, the licensee had failed to -
} report it to NRC or had failed to implement the corrective actions as agreed upon, enforcement action would be expected.
The adoption of a constraint is not needed to provide adequate protection of the public and the environment. The existing regulatory program of established limits in Part 20 and the application of ALARA is adequate for that purpose. Therefore, it is not necessary to promulgate the constraint as a limit.
The NRC does not agree that the constraint is less protective than Subpart I. Both Subpart I and the constraint require licensees to take actions to ensure that doset.to members of the public do not exceed 10 mrem /y from environmental air emissions. Enforcement would be similar under either j requirement routinely inspects licensed facilities to ensure that air effluer,ts do not result in doses to members of the public in excess of the requirements in Part 20. Confirmatory measurements are performed when they are deemed appropria,te 1-
& 9 4 hr pregrea e inspection and enforcement giYI FM" -
Am MAL be bp kacated as a result of this rulemaking.
3 Issue 4 - CITIZEN SUITS Comments: Three commenters opposed finalization of the constraint on the basis that it forfeits citizen rights to sue a licensee exceeding the constraint.
Response: The hck cf : cit her. 3 sit prevision in the Atmeic Er.cr y_
A&dT156F=: oppr;;r htcly a aatter f:r the CIA i.u cunsiu r 4-
[
eschit 4 + 't ag Final Constraint Rule 19 May 10, 1996
/,
rescirr Mr dec hica. Idowever. it should ha-notcd that- Commis sion's regulations in 10 CFR 2.206 provide the public with the right to petition the Commission to take enforcement action against a licensee for such things as a violation of the Commission's regulations. This would include the constraint rule when finalized.
-Issue 5 - AGREEMENT STATE COMPATIBILITY Comments: Four commenters addressed the proposal that the constraint be a division 2 matter of compatibility. Under division 2, States could adopt similar or more stringent requirements. Three commenters agreed that this rule should not be codified t.s a division 2 requirement, but rather as division 1. Under division 1, the States would be required to adopt
'[' regulations that were essentially identical. These commenters said that if
\
stricter standards were permitted, that reactors and non reactor licensees would be under different requirements, and that certain practices such as nuclear medicine could be jeopardized. One commenter noted that because this is really a limit, it should be under 5 20.1301 and would therefore be d A
division 1 matter of compatibility. Another commenter stated that NRC should have provided a greater opportunity for State involvement in this rulemaking, and that as a division 2 rule, Agreement States would have to spend scarce resources to develop a compatible rule.
Response: Section 116 of the Clean Air Act indicates that, with certain exceptions not applicable here, nothing in the Act precludes States from imposing air emission requirements that are more stringent than those Q-V Final Constraint Rule 20 May 10, 1996
d oped by EPA. Se )(9), which contains the provisions related to *2 L PA's " ample margin of safety determination for NRC or Agreement State 4-licenses, specifies that: "Nothing in this subsection shall preclude or deny the right of any State or political subdivision thereof to adopt or enforce any standard or limitation respecting emissions of radionuclides which is more 4*
stringent than the standard or limitation in effect under Section 7411 of this /
itle or this section." The Commission believes that this provision e>
Sh clarifies that EPA's determination regarding NRC an Agreement State licensees has no effect on the existing authority o tes to
/
impose air emission standards that are more stringent than those of EPA.
Accordingly, the Commission believes that the division 2 compatibility designation for the rule is consistent wit te authority in this area as described in the Clean Air Act. The division 2 designation means that Agreement States must address these rules in their regulations but may adopt
'd' requirements more restrictive than those of NRC. Accordingly, the power of the Agreement States to impose air emission standards under their Atomic Energy Act authority after the effective date of this rule will be consistent with their existing authority.
With regard to the comment concerning involvement of the Agreement States in the development of. this rule, NRC has routinely reported its progress on providing an adequate basis upon which EPA could rescind Subpart I to both the Organization of Agreement States (0AS) and the Conference of Radiation Control Program Directors (CRCPD) at each of their annual meetings.
The Agreement States were consulted extensively on this issue over the last several years. While they were not formally sent an advance copy of the draft
'( n\
\*) Final Constraint Rule 21 May 10, 1996
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T'
' rule, there were extensive discussions of the concept, not only with the pfts -
[
individual States, but also with the Executive Board of the v.3 . Reu en eF 9
bereement M Issue 6 - DEMOGRAPHIC INFORMATION CONTAINED IN REQUIRED REPORTS Comments:
o Seven commenters addressed the application of the requirement contained in i 20.2203 (b)(2) to the constraint. This section requires that reports contain demographic information on the exposed individual. These commenters expressed concern that a member of the public would be under no obligation to provide demographic information to licensees. Licensees would therefore not always be able to comply with the requirement.
Response: NRC agrees that members of the public may choose to withhold F the demographic information from licensees. Section 20.2203 has been changed
(
\ to delete that requirement.
Issue 7 - EFFECTIVE DATE Comment: One commenter requested that an effective date be added to the final rule to coincide with EPA's rescission of Subpart I.
Response: NRC agrees and this provision has been added. This provision is needed to ensure that there is not a time when both Subpart I and the constraint are in effect. Because it is very difficult to coordinate these rulemakings such that they are issued simultaneously, a delay in the effective date is appropriate.
A
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Final Constraint Rule 22 May 10, 1996 i
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p Issue 8 - ENFORCEMENT .
\v.l Comments: Five commenters ccx_..t S that NRC should establish a limit rather than a constraint. They stated that once the limit has been exceeded, a notice of violation and civil penalties should always result. One commenter expressed concern that "self-reporting and confession" is not adequate.
Another stated that because ALARA is 4ise=only guidance, it is not enforceable.
Response: A limit implies that doses must be controlled below that level in order to provide adequate protection of the health and safety of the ,
public and worke notice of violation and civil penalties are not neede s goensurethatlicenseeswillnotexceedaconstraint. Licensees are currently controlling effluents to levels below that which would be required under the constraint to meet current ALARA requirements. a licensee p
exceeds the constraint, the rule requires that corrective actions be taken in a timely fashion. If a licensee is uncooperative or fails to take appropriate actions, a notice of violation and civil penalties are possible.
I ALARA is not a guidance. As stated previously, the 1991 revision to 10 CFR Part 20 codified ALARA as a required part of the licensee's radiation protection program.
Issue 9 - EXEMPTIONS I
Comments: Five commenters stated that the rule should only apply ir, ^
members of the public off site. They cited.the Subpart I requirement to calculate dose to the nearest resident. Under Subpart I, licensees would not JQ N^'~j Final Constraint Rule 23 May 10, 1996 i
l
l A calculate doses from air emissions to visitors in hospitals, workers that are ij' not radiation workers within the facility, or other members of the public within the facility.
Response: NRC agrees that Subpart I only applies to the nearest resident. The language.in the rule has been changed to reflect that it is intended to apply to environmental air emissions. The guidance will be revised to indicate that the dose limit is to be calculated t he nearest resident. # f W 4,$ M Comments: Two commenters stated that air emissions from adjacent nearby exempt uranium mills should not be included in the calculation of dose. One commenter stated that materials from unlicensed portions of the facility such as ore stockpiles should not need to be considered in the calculation of dose.
Response: Subpart I does not apply to disposal at facilities regulated O)
\
V under 40 CFR Part 191, Subpart B, or to any uran:.m mill tailings pile after it has been disposed of under 40 CFR Part 192. The constraint applies to :
environmental emissions of licensed materials only. Therulelanguagehas]
been changed to make it clear that windblown particulates from other nearby V
licensed facilities or unlicensed materials need not be considered in the g9-calculation of doses used to demonstrate compliance with the constraint. J Comments: Four commenters stated that air emissions from patients should be exempted from this rule.
1 Response: NRC agrees that air emissions from patients are excluded from this rule. The Regulatory Impact Analysis for NRC's recent Patient Release D.
I Final Constraint Rule 24 May 10, 1996 l
1
('] Rulemaking (NUREG-1492), analyzed potential doses from exposure to patients
.having been released following administration of radiopharmaceuticals. This analysis concluded that internal doses from intakes of radioactive materials in the exhaled air of a released patient are trivial. For licensees using an inventory approach to demonstrating compliance with the rule, such as the COMPLY computer code, there is no need to account specifically for the materials that might be released to the air through respiration or transpiration by patients. The final regulatory guide will make it clear that
' dose from air emissions from patients need not be specifically addressed in the calculation of dose used to demonstrate compliance with the constraint.
Comments: Four commenters stated that in addition to Rn-222, all daughters produced after release should also be excluded.
-i (TI Response: Subpart I exempts both Rn-222 and any daughters produced
'V after release of Rn-222 as it is normally not attributable to licensed activities. The proposed rule was not intended to be more stringent than Subpart I. The rule language has been changed to reflect this exemption.
Comments: Two commenters recommended that in addition to Rn-222, Rn-220 and its daughters should also be exempted. One commenter stated that it was an EPA oversight that led to this erroneous omission from the final Subpart I.
Response: Rn-220 is normally attributable to licensed activities. EPA does not exempt Rn-220 or its daughters from consideration in the dose calculations in support of demonstrating compliance with Subpart I. The commenter$ suggestion'that an oversight led to the erroneous omission of this A
[D v Final Constraint Rule 25 May 10, 1996
~
exemption from Subpart I is incorrect. Therefore, Rn-220 will not be excluded !
'd from the calculations demonstrating compliance with the constraint.
Comments: Six commenters requested that in addition to sealed sources,
/
sealed containers should also be excluded from the rule.
p Response: -Paragraph 2(a) of Appendix D to 40 CFR 61 states gadioactive-materials in sealed packages that remain unopened, and have not leaked during ;
the assessment period should not be included in the calculations." Subpart I exempts: sealed packages, as any package that has remained sealed cannot >
, - Q: tribute to. airborne emissions. When a total inventory of licensed materials possessed during the year is used to model potential doses, it is
- unnecessary to include materials that could not have contributed to airborne emissions. The final regulatory guide will provide further guidance on this ,
- . . l issue. J
.v
, Issue 10 - MEASURABILITY OF 10 MREM / YEAR Comments: Three commenters stated that 10 mrem /y was not measurable.
One commenter stated that while 10 mrem /y might be easily achievable, it is p gnot easily measurable. Another stated that the exposure rate corresponds to a
1 microR/hr and cannot be measured accurately. I ldemonstratingcompliancewith Response: The regulatory guide provides several methods for Only one of the methods acceptable to staff-is direct' measurement at the receptor location. If this
/k, -
method is not practical due to the emission characteristics of the
- {
Final' Constraint Rule- 26 May-10, 1996
)
..: 3 radionuclide releases, there.are.several valid options cited in theggulatory
& 1 i
' Issue :11 -~. SCOPE OF THE RULE ;
J Comments: One comenter stated that if we must have a constraint, it ,
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1 should applyLto all licensees, not' just non-reactors. ]
Response: Although this rale only applies to licensees other than power I\
- reactor licensees,. the Commission's existing regulations in P rt 50,. -i
'E Appendix.I, already establish a similar regulatory frameworg- ndix I includes. separate requirements to develop design objectives and operational. -i levels sufficient to demonstrate compliance with Subpart I. In addition,.
reasto'r . licensees must report quantities of radioactive materials released in .
I air'and water annually, as well as the doses that result.
O l
1 Issue 12 - LOCATION OF CONSTRAINT IN NRC REGULATIONS I
-The Commission requested specific comment on the question of whether the 10 mrefconstraint should be established in 10 CFR Part 20, as proposed, or j l whether it should be established separately in each appropriate Part of Title-110 instead.
. Comments: Two coments were : received in-response to this issue. .One
? stated that:the constraint should be in Part 20.- Thelother stated that the' constraint'should'be~in'each. appropriate part. Two other commenters stated' -l
- FinaliConstraint1 Rule. 27 May 10, 1996 I l:
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(] that the constraint should be in i 20.1301 with dose limits.
Response: In order to make clear that the constraint is intended to l/
control do .o members of the public, but that it is not the same as a limit, it will be codified in a separate Suboart E to Part 20, " Dose constraints for members of the public."
t T
p0 MdY 'fMNA4 M N Summary of Changes in the Final Rule Based on the responsho comments, a few changes were made in the final '
rule. Otherwise, the final rule provisions are the same as those presented in the " background" section34 '.under the section titled proposed amendments. -
Specific changes made to the proposed rule in the final rule are summarized as follows. 1 m )
) (1) The requirement in i 20.2203(b)(2) has been changed to eliminate
. [Q the requirement to report the name, social security number, and date of birth
/
for each individual member of the public exposed to doses n excess of /
l limits or constraints.
(2) Paragraph 20.1101(d)(2) has been added to indicate that the effective date of the rule imposing the constraint is to coincide with EPA's rescission of 40 CFR 61, Subpart I.
(3) The language of the rule has been changed to indicate that Rn-222 and all daughters produced after the release of the radon are categorically excluded from this rule.
l} )
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Final Constraint Rule 28 May 10, 1996
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l A (4)l-The language of the rule has been changed to indicate that the ,
1 constraint . applies only to: environmental air emissions and thus dose to the~
nearest resident is to be constrained. ;
r f.l
. In addition, the following changes will be made to the regulatory guide:
..(1) An inventory _of radioactive materials used to model a potential dose to a member of the public need not include radioactive materials in
' sealed containers that have remained sealed throughout the compliance period. )
I (2) Airborne emissions of radioactive materials from patients need not i
. be considered if the materials have already been included in the site inventory.
(3) The example has been~ changed to demonstrate compliance with an environmental release constraint by calculating a dose to the nearest resident from a routine release point.
Finding of No Sionificant Environmental Impact i
I The Commission has determined under the National Environmental Policy j
[ Act of 1969, as amended, and the NRC's regulations in Subpart A of 10 CFR Part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore, an ;
environmental impact statement is not required. This action is not expected to have any significant ' environmental impact because the programs would )
, provide equivalent protection.- Actual air-emissions are not expected to
, ' change :The changes would~ be procedural methods for demonstrating compliance
' ~
-Final-Constraint Rule- 29 May 10, 1996- ,
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- +_ - - - -- _ _- -- - ---
i g
J
] cand' inspection procedures. The. environmental assessment and finding of no
, d ;significant' impact on which this. determination is based are available for i 1
- v. .
linspection'and photocopying for a fee at the NRC Public Document Room,' '
2120 L Street NW.-(Lower. Level), Washington, DC.
~
.I Paperwork Reduction Act Statement 1 I
-This final rule amends information collection requirements that are: l subject to the Paperwork Reduction Act of.1995 (44 U.S.C. 3501 et. Seq.).
l These requirements.were approved by the Office of Management and Budget, 'l approval number 3150-0014; The public reporting burden for this collection of information is estimated to average 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on.any aspect of this collection of information, including suggestions for further reducing this burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to bsjl@nrc. gov; and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-10202, (3150 -
0014), Office. of Management and Budget, Washington, DC 20503.
i
-l Final Constraint' Rule. 30 May 10,:1996
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O Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
P Regulatory Analysis The NRC has prepared a regulatory analysis for this final rule. The /
analysis cgelit:.!!=lrexamines the costs and benefits of the alternatives considered by the NRC. In the response to comments, the NRC concluded that only some minor changes to the draft regulatory analysis were necessary, corresponding to some minor procedural changes in the final rule. The )
~p regulatory analysis is available for inspection in the NRC Public Document
\ Room, 2120 L Street, NW. (Lower level), Washingtra, DC 20555-0001. Single
- copies of the analysis may be obtained from Charleea T. Raddatz, Office of 4
Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6215.
I Regulatory Flexibility Certification In accordance with the Regulatory Flexibility Act of 1980, (5 U.S.C. l 605(b)), the Commission certifies that this rule, if adopted, will not have a i significant economic impact on a substantial number of small entities. This final rule only impacts NRC licensees with emissions of significant quantities rh Final Constraint Rule 31 May 10, 1996
e ,.
fs- of radioactive material. Th'is category of licensee. includes only a few small s- businesses.
Small Business Regulatory En"orcement Fairness Act i
In accordance with.the Small Business Regulatory Enforcement Fairness Act.of 1996, the NRC has determined that this action is not a major _ rule and has verified this determination with the Office of Information and Regulatory
~ Affairs of OMB.
l Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this final rule because it does not apply to power reactor licensees, and therefore, that a backfit analysis is not required for this final rule l because these amendments do not involve any provisions which would impose l backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects In 10 CFR Part 20
)
Byproduct material, Criminal penalties, Licensed material, Nuclear ;
materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and' containers, Radiation protection, Reporting and recordkeeping requirements, Source material, Special nuclear material, Waste treatment and disposal,
\s_, .
Final Constraint Rule 32 May 10, 1996 *
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g'" ' For the reasons set out in the preamble and under the authority cf the
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Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendments to 10 CFR Part 20.
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION
- 1. The authority citation for Part 20 continues to read as follows:
AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f); secs. 201, as amended, 202, 206, 88 stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
7 -s i
)
E- 2. In 5 20.1003, the definition of Constraint is added to read as follows:
5 20.1003 Definitions.
Constraint (dose constraint) means a va3ue above which specified licensee actions are required.
- 3. In 5 20.1101 paragraph (d) is added to read as follows:
. 's )'
Final Constraint Rule 33 May 10, 1996
a
/~~'s -(l) To implement the ALARA requirements of 5 20.1101 (b), and (v) 'notwithstanding the requirements in 5 20.1301 of this part, licensees other than those subject to il 50.34a or 50.36b, shall constrain environmental air emissions of radioactive materials so that the individual member of the public likely to receive the highest dose will not be expected to receive a dose in excess of 10 mrem /yr TEDE from these emissions.
(2) If a licensee subject to this requirement exceeds this dose N
constraint, the licensee shall report the exceedgnce as provided in 5 20.2203 v and promptly take appropriate corrective action to ensure against recurrence.
(3) This requirement shall be effective on the effective date of the rescission by EPA of 40 CFR 61, Subpart I for NRC licensed facilities other than power reactors.
- 4. In i 20.2203 a new paragraph (a)(2)(vi) is added and paragraph (b)(1)(iv) is revised to read as follows: '
5 20.2203 Reports of exposures. radiation levels. and concentrations of radioactive material exceeding the constraints or limits.
(a)
(2)
(vi) The ALARA constraints for air emissions established under 5 20.1101(c); or (b)
(1)
(iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA A
Final Constraint. Rule 34 May 10, 1996
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constraints, generally applicable' environmental standards, and associated 7 ,
license conditions. ,
.(2) Each report filed pursuant to paragraph (a) of this section, for l
doses to occupationally exposed individuals in' excess of limits, must include
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- j. for each' individual - 4
];
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!- Dated at Rockville, Maryland, this day of. , 1996.-
For the Nuclear Regulatory Commission.
John C. Hoyle, Secretary of the Commission. -l l
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_( . . Final Constraint. Rule _35 May 10, 1996 i
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ATTACHMENT 2 REGULATORY ANALYSIS
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Regulatory Analysis for the NRC Constraint Rule on Q Radionuclide Air Emissions from NRC and Agreement State Licensees Other than Nuclear Power Reactors
- 1. Statement of Problem Radionuclide air emissions from Nuclear Regulatory Commission (NRC) :
licensees other than power reactors, and NRC Agreement State licensees are currently regulated by both the NRC (or Agreement State) and the Environmental Protection Agency (EPA). The NRC and Agreement State regulations have been issued under the authority of the Atomic Energy Act (AEA). The EPA regulations have been issued under the authority of the Clean Air Act (CAA).
The purpose of this Regulatory Analysis is to evaluate a final NRC rulemaking that provides assurance to the EPA that future emissions from NRC licensees h
f)
\ will not exceed levels that would provide an ample margin of safety. This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR Part 61 " National Emission Standards for Hazardous Air Pollutants" (NESHAPS), Subpart I, as it applies to NRC licensed facilities other than power reactors,%hereby relieving these NRC licensees from unnecessary dual regulati
. The EPA's regulations, 40 CFR Part 61, Subpart I, are currently in effect for all_NRC and Agreement State licensees, except power reactors. The dose standard contained within this regulation is not consistent with those of
- NRC in 10 CFR Part 20. The EPA dose standard in Subpart I is 10 mrem per
. fm . 1 EPA has rescinded Subpart I for power reactors based on requirements l( ) contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of v reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public.
e r
I' year, total effective dose equivalent (TEDE) for air emissions from any single facility.(buildings, structures, and operations on one contiguous site). This standard is different in both numerkcal value and approach to that of the NRC.
- The EPA approach to ensuring that dose limits adequately protect the. ;
public with an ample margin of safety is to limit individual pathways and i sources to a fraction' of the 100 mrem /yr TEDE limit for members of the public. !
The NRC approach to ensuring that doses'to members of the public are. !
adequately protective is to require compliance with an upper limit of 100' mrem per year TEDE from all pathways, and to the extent practical, maintain doses as far below this limi.
a a reascnably achievable (ALARA , taking into n
h account social and economic considerations and sound radiation protection ;
principles. .
There are three mechanisms for demonstrating compliance with the NRC 100
/]/
t V
mrem /yr TEDE limit and ALARA. For light water reactors, compliance is demonstrated if the design objectives in Appendix I to 10 CFR Part 50 are achieved. For other NRC and Agreement State licensees, compliance with the dose limit and the ALARA requirement is demonstrated in one of two ways. The first, is to demonstrate that the average concentrations in air and liquids ;
released from the facility do not exceed ues in Appendix B to 10 CFR .-
Part 20, and are ALARA, and direct exposures do not exceed 50 mrem /yr, and are ALARA; or second, to demonstrate that the dose to the member of the public likely to receive the highest dose from all pathways is less than 100 mrem /yr TEDE and is ALARA.
The NRC believes that-for its licensees the application of ALARA goals and guidelines has been successful in maintaining actual air emissions to n levels that are well below the EPA standard.
Pas ence and effluent x
V information reported to the NRC staff have 1cated that ALARA dose goals in s, a J
L the range of 10' mrem per year or less should be achievable for all materials ,
licensees, including fuel cycle facility licensees. Studies conducted by EPA
.(Ref.-1)concludedthatNRCandAgreementStatelicenseesare,ingenerak, maintaining air emissions and .resulting doses to members of the public well below the'10 mre tandard. This conclusion has been confirmed by a review of
- the annual reports submitted by licensees to EPA as required by Subpart I.
For 1993, only one licensee reported air emissions above the 10 mrem per year standard; corrective measures were initiated by the licensee and no ienforcement actions were taken by EPA.
This rulemaking establishes a 10 mrem per year TEDE dose constraint on radionuclide air emissions. While not considered a health and safety issue such that adequate protection of the public health and safety would not be assured otherwise, this re ulatory action ensures that air emissions are j9 maintained at a very lo evel, at little or no incremental cost (and
- \'j considering the elimination of dual regulation, a net savings), and bring consistency between EPA's dose standard and the NRC's ALARA application, thereby providing EPA with a basis upon which to rescind Subpart I as it applies to NRC licensed facilities other than power reactors.
1.1 Background on EPA's Implementation of Radionuclide NESHAPs for NRC Licensed Facilities The 1977 amendments to the CAA require'd EPA to consider whether radionuclides should be identified as a hazardous air pollutant' and, if so, to adopt standards to limit their emissions. Section 122(c)(2) of this 1977
.m - amendment also required EPA and NRC to enter into a cooperative agreement to
( I y/ minimize duplication of effort and conserve resources in establishing, f1 "
4 implementing, and enforcing standards for airborne radionuclide emissions from
/^')
sources and facilities licensed by NRC. In 1979 EPA subsequently identified radionuclides as a hazardous air pollutant (44 FR 76738; December 27, 1979).
In April 1983, EPA proposed standards regulating radionuclide air ;
emissions from four (4) source categories, with one being NRC licensed facilities. In October 1984, EPA withdrew the proposed emission standards for certain sources, including NRC licensed facilities, based on a finding that controls already in-place protected the public with an " ample margin of safety" (48 FR 15076; April 6,1983). In July 1987, the U. S. Court of Appeals for the District of Columbia Circuit, remanded to EPA the air emission standard for vinyl chloride because the Court found that EPA had improperly l considered cost and technological feasibility in setting the standard without i
first determining a sufficient level of protection as required by the CAA. l
[3 Later that year, EPA petitioned the Court for a voluntary remand of its
\") existing air emission standard for radionuclides. In March 1989, EPA proposed a revised emission standard of 10 mrem /yr TEDE for NRC and Agreement State licensed facilities. This standard was established based on the concept of an
" ample margin of safety" as directed by the Court in its remand of the vinyl chloride NESHAP.
On December 15, 1989 (54 FR 51654), the EPA issued its final rule on the NESHAPs under Section 112 of the CAA for emissions of radionuclides from numerous source categories, with one category including NRC and Agreement State licensees. The rule was issued as 40 CFR Part 61. Subpart I of this rule pertained to NRC and Agreement State licensees. The standard states that air emissions of radionuclides shall not cause any member of the public to
- receive more than 10 mrem TEDE in any year, or more than 3 mrem TEDE from k (qJ radioiodines. Radon-222 and its decay products formed after release from the) \ ;
4 [ .
s Q0
/
/] facilityareexcluded,gEffectivewiththeissuance,however,wasastayon Subpart I, which delayed the effective date of that part of the rule covering NRC and Agreement State licensees. Subpart I was stayed until March 15, 1990, to allow EPA time to consider concerns raised, in particular, by the NRC and the National Institute of Health (NIH) (Yan NRC licensee) about unnecessary __
duplicative, and perhaps conflicting, standards
~
eng&
RC licensees.
/ =
At the-time of issuance of the rule, the EPA reaffirmed a previously stated position that it "... continues to believe existing emissions from these sources [NRC licensees) are already so low that the public health and safety is already protected with an ample margin of safety" (50 FR 5190; February 6, 1985). The NRC had raised concerns about whether regulation of its licensees under the CAA provided any additional public health and safety benefit. The x NIH, as an NRC licensee, voiced concerns about the potential negative effects of the dual standards on the use of nuclear medicine. Even recognizing these concerns, the EPA decided it was legally bound to include Subpart I in its final rule promulgation due to court-ordered deadlines. A 60-day comment period was established for the purpose of receiving further information and comments related to these concerns: a 3 month stay of Subpart I was effected to allow further consideration.
The 1990 amendments to the CAA included provisions in Section 112(d)(9) that allow EPA to decline regulating airborne radionuclide emissions from NRC licensed facilities if it determines, through a rulemaking, that NRC's program provides protection of the public health with an " ample margin of safety."
This legislative initiative, referred to as the Simpson Amendment, created the framework for cooperat e activities between the agencies, which supported the 40(fitP*4 / /
rescission of Subpart T -
nd Subpart I for power reactor [s ,ef 10 Cr", Part $1.=
5
/O Subpart'T covers radon emissions from disposed uranium mill tailings at-sites where' operations have ceased (59 FR 36280; July 'i, 1994).
On April 24, 1991, the EPA issued a final stay until November 15, 1992,
] ,
for all NRC and Agreement' State licensees, except power reactors, which under
^
separate ruling had been stayed indefinitely pending the rulemaking on Subpart I rescission (5A FR 18735; April 24, 1991). During this period of stay, EPA conducted two studies of the air emissions from NRC and Agreement 1
State material licensees for the purpose of evaluating the state of compliance. The first was a survey of 367 randomly selected nuclear material licensees. . The highest estimated dose to a member of the public from air emissions was 8 mrem per year TEDE, based on very conservative modeling. In I 1
addition, 98 percent of the facilities surveyed had doses of less than 1 mrem per year from air emissions.
O The second EPA study evaluated doses from air emissions from 43 additional facilities that were selected because of their potential for air emissions with calculated annual doses to members of the public at a sizable
/
fraction of the lu mre djsestandard.,Ofthese,75percenthadestimated [
maximum dosho a member of the publicdf ess than 1 mrem per year. None exceeded the 10 mre tandard.
b The results of these studies were published by '
EPA (57 FR 56877; Dec 1, 1992) and, in summary, showed that radionuclide air emissions from the NRC and Agreement State licensees were typically, with the potential for few exceptions, well within the EPA's CAA standard of 10 mrem per year.-
EPA's conclusion, based in part on _these studies, was that the current NRC program, which limits public dose to 100 mrem per year, in concert with
- the requirement _to keep doses ALARA, has been successful in maintaining air
. '(
A_ emissions well below the"10 mrem per year-subpart I standard. However, 6
sr , , --
.p, because of EPA's concern regarding the litigative risk of extending stays of O prev lypromulgatedNESHAPsdurin{ pendency)fa'rescissionrulemaking,and
?
actp the DC Circuit hablready reversed the previous stay for licensees other than power reactors, the stay on Subpart I was allowed to expire by its own terms-on November 15, 1992 (57 FR 56877).
In July 1993,-the EPA Administrator determined that there was insufficient basis at that time to rescind Subpart I. Concerns remained about the NRC's Agreement State program and the fact that there was no mechanism to ensure doses from air emissions would remain below 10 mrem per year in the absence of Subpart I. Consequently, licensed facilities other than power :
reactors are currently subject to dual regulation of air emissions of radionuclides under both the AEA and the CAA, with dual regulatory oversight by EPA (and/or authorized States) and NRC (or Agreement States).
/
(
l.2 Past NRC and EPA Efforts to Rescind Subpart I Under the Simpson Amendment Over the past 15 years, the NRC and EPA have worked together on the objective of eliminating the duplicate regulatory oversight. The NRC and EPA entered into a Memorandum of Understanding (MOU) in November 1980 to work together in developing mutually acceptable procedures for implementing and enforcing EPA's standards in accordance with Section 122(c)(2) of the CAA (45 FR 72980; November 3,1980). The 1980 MOV stated, "Under this agreement EPA shall promulgate standards .for airborne radionuclide emissions under its Clean Air Act authority and NRC shall have the primary role in implementing
,m and enforcing these standards where applicable for sources and facilities licensed by NRC."
7
I's In 1990, Congress amended the CAA specifically addressing the issue of
\ 'd )
duplicate regulation. This amendment enacted Section 112(d)(9) of the Act.
It included provisions whereby standards for radionuclide emissions from NRC (or NRC Agreement State) licensees would not need to be promulgated, if the EPA Administrator determined, by rule and after consultation with the NRC, that the regulatory programs established by the NRC provide an " ample margin of safety" to protect the public health. Under these conditions, radionuclide NESHAPs for NRC and Agreement State licensees would not be required. This provision was enacted to enable EPA to eliminate duplicate regulation and eliminate redundant efforts between EPA's and NRC's regulatory programs.
In 1992, EPA proposed rescission of Subpart I, and subsequently allowed it to become effective, and NRC and EPA issued an MOU (57 FR 60778; December 22,1992). Its intent was to determine NRC actions that could form
[] the basis for EPA to rescind Subpart I. NRC was to put in place additional regulatory guidance to ensure air emissions would be maintained at a level consistent with the level of protection afforded under EPA's Subpart I, i.e., l
" ample margin of safety." NRC was to develop and issue regulatory guidance ;
for its licensees, other than power reactors, on designing and implementing a radiation protection program to ensure that doses resulting from effluents would remain ALARA. NRC also agreed to develop inspection guidance on ALARA considerations for effluents and incorporate ALARA in its Standard Review Plans. NRC was to work with Agreement States to adopt and implement a compatible program. EPA was to develop and publish in the Federal Register a Notice of Proposed Rulemaking, pursuant to its authority under the CAA, Section ll2(d)(9), to rescind its existing regulations of 40 CFR Part 61,
,- Subpart 1, as applied to licensed facilities other than power reactors.
!V}
8
s
(-
if As an implementation of its ALARA guidelines, the NRC developed. [
'(' .
T
. Regulatory Guide 8.37, which. included a specific ALARA goal of 10 mrem per. .
. i
~
year. TEDE to the maximally. exposed individual from radionuclide air emissions ;
.(Ref2).- Additionally, Inspection Procedure (IP) 87102 was developed to
- include ~a review of emissions from those facilities with the potential .of !
n .. :
[
- exceeding 20 percent of the 10 CFR 20, Appendix B, Table 2 values (Ref. 3). .
k l
Generally, this 20 percent level corresponds to a calculated dose from air. ;
. exposure of 10 mrem per year, which is comparable with the EPA's Subpart I
. . standard.' An' Inspection Referral Form was included within IP 87102, which is
~
- 4 to be completed by the NRC inspector and forwarded by NRC Region Management to the cognizant egional Radiation Program Manager, f the E^A.-
b e- i Under the Simpson Amendment and the 1992 MOU, EPA agreed to propose a j rulemaking rescinding its existing regulatinns in 40 CFR Part 61, Subpart I, l 4
p as applied to licensed facilities other than nuclear power reactors (56 FR
, 18735;fApril 24, 1991). EPA announced its intent to propose rescission of Subpart I (57 FR 43173; September 18,1992); and later in 1992, EPA issued the Federal Register notice proposing the rescission (57 FR 56877; December 14, t 1992). However, on November 15, 1992, EPA allowed the stay on Subpart I to expire'for facilities other than power reactors. This action was taken because 'of substantial doubts-that EPA had concerning the legality of any
-further. stay. A September 22, 1992, DC' Court ruling in response to a Natural.
^
' authority lbystayingSubpart.I-for.facilitiesotherthanpower. reactors,while it was. collecting information to make a finding under Section.112(d)(9) p .
- (Simpson Amendment). Following this determination, in-July 1993, the EPA yy ' Administrator decided-there was insufficient regulatory basis to rescind U 1Sub'partzi.
9 i
l
[ In its January 28, 1994 Federal Register notice (59 FR 4228), EPA
\ .
stated:
At this time, EPA has not taken final administrative action concerning the rule to rescind Subpart'I for NRC and Agreement State licensees other than commercial. nuclear power reactors which it proposed on December 1, 1992. EPA is recommending that NRC make certain changes in its regulatory program in order to fully support the substantive finding
'which is required by CAA Section ll2(d)(9) before EPA may rescind Subpart I for NRC licensees other than commercial nuclear power reactors.
EPA has historically identified two components to this finding: ) that the facilities licensed by NRC and Agreement States are currently in ,
compliance with the quantitative emission limits in Subpart I (10 mrem per year,TEDE),and(2)thattheNRCprogrammustbesufficienttoensurethat #
A l emissions would remain below this level in the future, thereby protecting the l public with an ample margin of safety.
1.3 Issue of Unnecessary and Conflicting Dose Standards The issues surrounding the necessity for duplicate regulation relate to i EPA's 'need to demonstrate an " ample margin of safety" as called for in the CAA.
Past studies conducted by the EPA have_ indicated that, except for unusual cases, all.NRC and Agreement State licensees currently subjected to Subpart I meet the Subpart I' dose standard. NRC's reviews of licensees' air emissions p\ - further support the position 'that the ALARA goals of Regulatory Guide 8.37 are
(
L/ consistently being met. For the calendar year 1993, the first year under 10
i
[. -
y- ,
l O \
which Subpart I reporting was required, EPA received approximately 670 reports t
\ d 'from NRC and Agreement State licensed facilities. Of these, approximately 30
~
j reported' doses greater than 10 mrem /yr from air emissions. EPA staff told NRC j staff that after clarification with several facilities in their use of the i
COMPLY code, only one licensee had radioactive air emissions in excess of the ;
Subpart I dose standard. This licensee took corrective measures; no i I
enforcement actions were taken by EPA. The 1995 annual reports are currently being submitted to EPA, and the reports reviewed to date have not identified any licensee with air emissions above the Subpart I standard. ]
1 The dual regulations by EPA and NRC are considered unnecessary for the I following reasons. First, the level of air emissions from NRC licensed ;
i facilities has historically been well below the NRC's dose limit. The application of the ALARA principle has resulted in facility programs and
_ emissions that, except for a few unusual cases, readily meet the EPA standard.
These unusual situations are best addressed on a case-by-case basis. Second, 1
-with this level of compliance, subjecting facilities to dual reviews, reporting, evaluations, and inspections is unnecessary for protecting the public safety. Compliance can most efficiently be covered by a single regulatory process. The NRC constraint rule provides an ample margin of l safety.
EPA's compliance program relies primarily on evaluations and reports prepared by the facility. . Licensees emitting radionuclides in amounts that would cause doses less than 10 percent of the Subpart I limits (e.g., < 1 l
mrem /yr TEDE) are. exempt from the reporting requirement but must still monitor effluents and maintain t -cords of dose calculations.
. Licensees subject to
& /i j.s -Subpart I annual reporting requirements (e.g., doses > I mrem /yr TEDE) are required-to submit an annual report y. March 31 of each-year to EPA n air -
11 4
~
'\ emissions for the previous calendar year. Licensees with air emissions in excess of the annual limit (e.g., > 10 mrem /yr TEDE) must include in the report proposed corrective measures to ensure future doses will be below the limit and report on a monthly basis until EPA determines that adequate l
corrective measures have been taken and reporting is no longer necessary. ,
1 There are currently about 7,000 NRC licensed facilities and about 15,000 Agreement State' licensees. About half of these facilities use radioactive materials in the form of sealed sources (i.e., contained within a metal or i other material casing). These licensees are not subject to Subpart I because of the negligible potential for any significant air emissions (see )
40 CFR 61.100 applicability). The facilities (other than power reactors) with potential air emissions for which compliance evaluations are required are those that use materials in unsealed form, predominantly hospitals, clinics, radiopharmacies, research and academic facilities, fuel cycle facilities, and research reactors.
The CAA, as amended, establishes in Section 112(1)(1) the basis upon 'j which States may submit to the EPA Administrator a program for implementing l i
and enforcing emission standards for hazardous air pollutants for stationary
~
sources located in such State. The States are.not-authorized to set standards f - - -
(Q dWW Oh ksrstringent-thadhose promulgated by the EPA. fe EPA AdmiYiistrator has g
t at4Mhp roved-a y tesfor Subpart I implementation. Presently, j h h seven States are engaged in a demonstration program with the EPA focusing on the development of State compliance programs needed for implementation of L radionuclide NESHAPs, covering NRC licensed. facilities, DOE facilities, and l
other miscellaneous sources covered by 40 CFR Part 61. I
!/9 k}
12 i
- e. I e
1.4 Agreement States j V Under the provisions of Section 274(b) of the Atomic Energy Act (AEA) of 1954, as amended, certain States have assumed-the responsibility and authority for regulating radioactive material (byproduct material, source material, and special nuclear material in limited quantities) users within such State.
These NRC Agreement States' rules and regulations replace those of NRC.
However, adequacy and compatibility are assured because the AEA includes a provision that the Commission must find that the State program is compatible with the Commission's program for regulation of such materials, and that the i State program is adequate to protect the public health and safety with respect ,
to the materials covered by the proposed agreement.
i Conforming. regulations enacted by Agreement States are essentially !
[ identical, in level of protection afforded, to those of the Commission. )
\,
Associated guidance and inspection efforts are normally similar. I
- 2. Objectives of Rulemaking The objective of the rulemaking is to provide assurance that future emissions from NRC licensees will not exceed levels that will provide an ample margin of safety. This action is expected to be the final step in providing l
EPA'with 'a basis upon which to rescind 40 CFR Part 61 " National Emission Standards fo ardous' Air Pollutants," Subpart I, as it applies to NRC i 111 ties other than power rea'ctors, thereby relieving these -
licensees from unnecessary dual regulations. To support the determination by n EPA that NRC's programs provide an equivalent level of protection, this l U
13 i
t l; y !
l
- ,s.
- [ rulemaking' codifies a 10 mrem per year dose constraint applicable to NRC j iicensed facilities, excluding power reactors.
J This rulemaking, followed by an EPA rescission of Subpart I, will ]
eliminate duplicate. regulatory oversight of NRC and Agreement State licensees ]
4 by EPA under the CAA and lessen the burden of regulatory compliance on j 1
licensees. It will eliminate redundancy in the regulatory processes between H NRC and EPA, thereby reducing government's oversight effort. The resulting .
cost savings will be achieved while maintaining r" "
, th e same margin of "
public and environmental safety as that currently afforded under Subpart I.
L /With the elimination of dual regulation /, the burden of implemer.tation and _
[ continued demonstration of compliance'with duplicate regulations by the users will be reduced.- Efforts will be reduced for maintaining compliance and enforcement programs by two separate government agencies for the same emission j
. O source. EPA will be able to eliminate its continuing efforts required for
- maintaining a compliance evaluation program for NRC and Agreement State .
--licensees, including developing and maintaining guidance programs, training of EPA regional staff, transition of authority to States, training of State agencies, reviewing emission reports, reviewing construction and modif 7*.ico i applications, and, as required, conducting enforcement actions. NRC's programs will require essentially no additional efforts beyond its current inspection and enforcement programs. Agreement States have un'LA sLV p similar compliance -
evaluation programs, if they have not already done so.
- 3. > Alternatives
- 11) Alternative 1 - Dual Regulation - NRC and EPA would each retain v - - -
b existing regulations and compliance programs.
14
__ _ _ _ _ _ =
4 i
[- . . .
4
[ \
- 2) Alternative 2 - EPA Regulations Only - Revise NRC requirements to
\.
eliminate air effluents.
- 3) Alternative 3 - NRC Constraint Rulemaking and EPA Rescission of Subpart 1. Codify constraint dose levels for air emissions from NRC licensed facilities (other than power reactors). _
k Each alternative is discussed below. ;
3.1 Alternative 1 - Dual Regulation J
There is general agreement between NRC and EPA that with few exceptions, I all NRC and Agreement State licensed facilities are maintaining air emissions .
l wel1 below the 40 CFR Part 61, Subpart I, dose standard of 10 mrem per '
('
) year.' However, EPA determined that NRC's regulatory framework did not fully support the substantive finding which is required by CAA Section 112(d)(9) J before EPA may rescind Subpart I for NRC licensees other than power reactors
-(59 FR 4228, January 28,1994).
Under this approach, NRC and EPA would each continue its existing i
regulatory requirements and compliance programs without substantive changes to reduce any burden of dual regulatory oversight. The NRC's inspection program would continue to provide o ite inspections and reviews of ALARA goals, -
which, in effect, would afford a basis for evaluating compliance with the dose l l
standards of Subpart 1. .NRC would continue to provide letter summaries to EPA .l l
on licensee compliance. However, NRC would not be involved from a legal q l
l p
i
-2 Refer to the. Federal Register Notice (54 FR 51654) promulgating Subpart I and EPA's subsequent. study of-radionuclide air emissions for NRC licensed I
bj facilities -(Ref.1) . ;
15
i compliance standpoint if a facility exceeded the standard, unless NRC standar'ds were also exceeded. EPA would retain its regulatory authority for L
-enforcement' actions.
EPA would' continue its compliance programs, including developing and maintaining guidance programs, training of EPA' regional staff, transition of - .
- authority to States, training of State agencies, reviewing emission reports, ;
reviewing. construction and modification applications, and as required, ;
conducting enforcement actions. Many States can be expected to develop !
. corresponding regulatory requirements with licensing (fee) and inspection f
programs under the authority of Section 112(1)(1) of the CAA.
The availability of citizen suits under the CAA would remain if Subpart I is not rescinded (hwever, if EPA.does ultimately rescind, the '
l public petition process for NRC enforcement action against.a licensee under j
,O 10 CFR 2.206 would offset the unavailability of the CAA citizen suit [
provision; however, judicial review of 2.206 petition denials is not readily available. EPf S:: :t:tsd-that CCi curr eid . ;;ulatcry fr==r' did . ut 'l - .
pr.mtide- a-strffkied legal ed technic & basis for ren.i. ding Sdp;rt I (50, D-
-4228;mlaT1uary 26, iH4) While not supporting a timely rescission.of Subpart I, maintaining dual regulation would allow time for EPA to gain 4
additional experience with the implementation of the Subpart I standard on NRC and Agreement State licensees. Over a period of time, this experience could provide the necessary information to support a decision by EPA to rescind Subpart'!.-
v g: 16
i I
[ 3.2 Alternative 2 - EPA Regulation Only q
' L]/ l
. )
Under this alternative, NRC would make a finding that the EPA regulatory l framework adequately protects members of the public. from air effluents of NRC licensees. Inspection Procedure IP-87102, Regulatory Guide 8.37 and the MOU with EPA on inspection referrals would be withdrawn. Section 20.1302 would be .
l revised to indicate that compliance with Subpart I is sufficient to '
' demonstrate that dose from air effluents does not exceed 10. mrem /yr.
Appendix B, Table 2, Column 1 to Part 20 would be deleted.
1
, As in Alternative 1, EPA would continue its. compliance programs and citizen suits under the CAA would remain.
3.3 Alternative 3 - Constraint Rulemaking C
'(
This alternative addresses NRC's development of a regulatory constraint within 10 CFR Part 20 on allowable air emissions from NRC licensed facilities, excluding power reactors. The regulation would constrain air emissions to a level corresponding to a calculated dose of 10 mrem per year to the maximally exposed member of the'public. This approach would add numerical criteria for material and fuel cycle facilities and test and research reactors, similar to that already in place for nuclear power reactors (i.e.,55 50.34a, 50.36a, and Appendix I to Part 50). It would not be a regulatory limit. k-tTcensee exceeding a limit would be in -violation of NRC regulations and subject to ,
enforcement. A 14 c=ce ' exceedin;; :-cenr+ r= 4 at ="'d be rcgi red + a <"h=4+ = -
rppert, W race rad cr.d 'imple...wi, app,u gi @ c ~ rect h aui. ions.. Failure 6 to report exceed ce of the constraint or failure to implement agreed upon corrective actions would be a violation of NRC regulations subject to 17 I
- . - - ~ . _ . - _
[ enforcement acti Licensees exceeding the constraint level would be
]re bmitt a-report to the NRC identifying the situation and pppropriate measures' f_o_r reducing emissions to below the constraint. EPA t staff has indicated in meetings with NRC staff that this approach would 4 provide .a sufficient legal and regulatory framework upon which EPA could rescind its regulation of Subpart I. ,
In accordance with Section 112(d)(9) of the CAA, for EPA to rescind i
Subpart I, a finding must be made that there is no decrease in the level of f
protection afforded the public. Therefore, the NRC rulemaking evaluated under this approach would be to impose a dose constraint that would provide ;
compatibility with EPA's dose standard of Subpart I. An ALARA dose constraint of 10 mrem per year TEDE to members ~of the public from air emissions of ;
[3 radionuclides would provide consistency.- These requirements, codified within U NRC's regulations, would provide a sufficient regulatory framework, thereby l
I I'
supporting a finding by EPA that NRC's regulations provide an ample margin of safety."
l
- 4. Consequences This Regulatory Analysis does not address a serious health and safety )
issue. Instead, the basis for evaluating consequences is eliminating regulations.thatareconsideredduplicat'gandunnecessary. The consequences /
are evaluated against a baseline comparison.
/** l
'('
18 i i
4 f' 4. l' Dual' Regul'ation k '
Dual regulation would not support a t' , ,limination of duplicate EPA ,
and NRC regulation. It would not reduce ,
c ent level of effort for the EPA in its compliance programs. NRC's eins ;tw and referral efforts would
'also be expected to be maintained to meet its regulatory responsibilities under the AEA and to fulfill the 1992 M0V with EPA. NRC and Agreement State
-licensees would continue to be subjected to dual regulation.
NRC and Agreement State licensees would have different regulatory requirements addressing air emissions within two different titles of the Code of Federal Regulation (i.e., Title 10 for the NRC and Title 40 for EPA). In addition, as individual States establish their EPA 40 CFR Part 61 compatible programs, licensees would be subjected to another, and potentially different, compliance program. Each licensee would have tt:c regulatory groups within a State with whom to interact relative to compliance, including on-site inspections, methods for demonstrating cor.pilance, licensing reviews (for NRC i programs), facility modification reviews (EPA), and recordkeeping and reporting. Some Agreement State representatives have stated that qualified -
radiation protection personnel may move from the radiation protection program to the environmental program to administer Subpart I. This might result in personnel shortages in some States. Maintaining enough qualified radiation protection personnel has consistently been a problem for many State programs, increased efforts are associated with duplicate requirements, duplicate implementation programs-and duplicate regulatory inspections.
Maintaining dual regulation would not require a rulemaking. NRC's
. (q
)
current regulatory programs would continue to support the established
\_.) - radiation protection _ framework in 10 CFR Part 20, including the dose limit of 19
100 mrem per year and the principle of ALARA. EPA's compliance programs would continue, including the selected inspections, evaluations of licensee submitted annual reports, and continued support to individual State program development. EPA staff has indicated that they expect individual State involvement would increase as individual compliance programs are put in place.
Based on thi: 1992 NRC/ EPA MOU, NRC has provided assistance through its inspection program to EPA for its Subpart I implementation. As an implementation of its ALARA guidelines and based in part on this MOU, the NRC revised its Inspection Procedure 87102 to include a review of emissions from those facilities with the potential of exceeding 20 percent of the 10 CFR Part 20, Appendix B, Table 2 values (Ref. 3). The procedure requires that an Inspection Referral Form be completed by the NRC inspector and forwarded by y NRC regional management to the cognizant EPA Regional Radiation Program , \M f Manager, ph@ h Based on EPA labor rates, the cost of Subpart I to licensees p $517 per licensee or over $3 million per year for all licensees. EPA estimated the burden to NRC and Agreement Stateflicensees assuming that 6000 licensees would be affected and using 3 separat 4 urly rates for professional ($27/hr),
managerial ($38/hr) and cle i ad ($10/hr) personnel.
The burden estimap n EPA's OMB clearance assume that 200 licensees [
\
file reports anhuhlly and that it will require 11 staff hours to review each report. EPA estimated government burden for Subpart I is 2200 ho g Thq L /
/
hf04 . fft' Sir e 989,tTRC as devoted about 15 FTE to the Subpart I issue. Thilb M ( g effort has consisted of interface with EPA in support of rescission, b d dl m
development of Regulatory Guide 8.37 ("ALARA For Effluents For Materials n' Facilities"), development of inspection guidance, inspection efforts, referral 20
fl
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of inspection results to EPA, and development of the Constraint Rule. Under
'/
this alternative, it is expected that EPA's burden would remain at about 3 FTE annually, with periods of increased effort when facilities experience increased air emissions at or above the standard. NRC and Agreement State licensees' efforts can be expected to remain at about 138,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> annually (23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> / licensee), provided facility design and/or operations do not -
V significantly change. Licensees would continue to have to demonstrate x $pY compliance with dual regulatory requirements. h' The burden of Alternative - 1 is summarized in the following table: .
g 0,Wi6 A -
/ '
[ b d Cost NRC a 1d Agreement State Licensees C33,100,000, 4 ~
EPA kn (3p76-p 4d7, 44,600 NRC(k5FTE)forinspectionandreferralsioEPA) 50,000 h Yf, TOTAL $3,194,600 y .
4.2 Eliminate NRC Regulation of Air Emissions .
Elimination of NRC regulation of air emissions would eliminate dual regulation. NRC's burden would be reduced as inspection of licensee records would no longer be performed. Agreement States radiation program concerns !
relative to the loss of qualified radiation protection personnel to State environmental programs would not be resolved. However, States would not have to enforce duplicative regulations in each of these programs.
Elimination of NRC regulations of air emissions would require rulemaking
, to revise 5 20.1302. This revision would be necessary to make clear that NRC
! \
/ inspection and enforcement of compliance with public dose limits would not 21
include air emissions unless the dose from direct exposure and liquid
[~^)
effluents exceeded 90 mrem /yr TEDE. It is expected that this rulemaking would take approximately 1 FTE over a 2-year period. Similar revisions to Agreement State rt;gulations would be needed. Because of the simplicity of this rulemaking, it is estimated that each of 29 Agreement States would expend about 0.1 FTE revising their rules.
The burden on licensees and on EPA would be the same as under the dual regulation alternative. The annual burden to NRC would be slightly reduced as routine-inspection of doses to members of the public would include only direct exposures and liquid effluents. As air effluents are a very small portion of doses to members of the public for most facilities, this burden reduction is expected to be very small.
The burden associated with Alternative - 2 is summarized in the tables
[D below:
Annual-Burdens Cost NRC and Agreement State Licensees $3,100,000 EPA 44,6N NRC (reduced inspection burden 0.25 FTE) -25,000 TOTAL $3,119,600 One Time Expenditures. FTE- Costs NRC Rulemaking 1.0 $100k NRC Inspection Procedures and Inspector Training 0.5 50k Agreement State Regulations Revision 2.9 290k f3 TOTALS 4.4 $440k
(.
22
a i Alternative 3 - Constraint Rule
(
I A' constraint level would be enforced by NRC through its current licensing and inspection and enforcement programs. The current IP'87102- i
'(Ref 3) would require minor modification in wording for consistency with the rule; the Referral Form and letter to EPA would no longer be needed. NRC regulatory guidance would be revised to specifically address the constraint rule. Acceptable methods for demonstrating compliance and reporting guidelines would need to be added. For licensees, an overall simplification in compliance assessment methods would be expected due to the streamlining of methods needed for both Subpart I compliance and 10 CFR Part 20 compliance.
The main savings would be'for facilities that maintain effluents at a small fraction of the standard, i.e., those facilities for whom additional evaluations, reports and overall dual regulatory oversight are not required
')
' for ensuring public safety with an ample margin of safety. Annual reporting )
1 1
would not be required provided air emissions were maintained below the NRC's constraint level. NRC's routine inspection program would provide the necessary regulatory oversight.
Licensees who exceeded the constraint level would be required to submit a report to NRC and to develop and implement corrective measures in keeping )
with ALARA, to reduce air emissions to within the constraint level.
I Enforcement actions would only be taken for those facilities that fail to perform the required evaluations and/or those facilities that fail to take appropriate measures .. 4 .., atADA for reducing air emissions. 'l Because doses from air effluents are currently being calculated using fg Appendix B.to 10 CFR Part 20. to demonstrate compliance with the public dose
- limits,~no additional effort would be expended to demonstrate compliance with 23 l
4 fy
['N the constraint rule if the dose did not exceed Very few licensees (if -- -
'~' > any) would have doses to members of the public in excess of the 10 mrem /y constraint, and therefore be required to make a report to NRC or an Agreement State. It is assumed that an avera of three reports per year will be (thrN is dstimated to be $12,000 annually received. The total licensee.burde -
b (3 reports /yr x 80 licensee-hours / report x $50/hr - $12k/yr).
The burden of reviewing the air effluent control programs of licensees reporting doses to members of the public in excess of the constraint is estimated to be $24,000 annually (3 reports /yr x 160 NRC staff-hours / report' x $50/NRC staff-br = $24k/yr)
The constraint rule is not considered a necessary public health and safety measure because adequate protection has been maintained. Therefore, efforts associated with the rulemaking would be limited to mainly 2 O administrative efforts for the preparation of appropriate legal notices and issuance. The basi or the rulemaking would be the elimination of unnecessaryduplicatgregulatoryoversight. Public hearings, additional technical reviews, etc. would not be anticipated. j Under Alternative 3, NRC and the Agreement States would incur one time costs for completion of the rulemaking, development of regulatory guidance, -
l modification of the 'MMF inspection procedures and training of 9RC inspection
/
personnel. EPA will also incur one time costs for the rescission of .
l Subpart I.
The constraint rule would be categorized as one of Division II l l
compatibility under the current NRC Policy Statement governing the Agreement j 3 This estimate is based on NMSS assumption that 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> would be expended l jo (V )
per report. This cost includes a reactive special inspection, recalculation of dose, and gLodification of the facility license to incorporate approved corrective actions as license condition- with headquarters concurrence. g(V
[ j l
24 M 4'y f i
4 d
State Program (January 23, 1981; 46 FR 7540, July 16, 1981; 46 FR 36969, i/*)
V July 21,1983; 48 FR 33376).' As such, Agreement States may choose to adopt a rule that is more restrictive but no less restrictive than the one approved by the Commission. Agreement States would have three years to adopt the compatible or more -stringent regulations. The Agreement States are expected to adopt similar compliance programs guidance (i.e., regulatory guidance and inspection procedures). Therefore, the potentially significant . impact would ,
be that associated with a rulemaking. For cost comparisons, it is assumed that'the 29 NRC Agreement States would each adopt a rule and compliance program similar to that of the NRC's.
Currently, Agreement States have programs in place that implement and enforce the 10 CFR Part 20 dose limits and ALARA guidelines. Therefore, based on NRC's precedence in establishing the regulatory framework for a constraint rule, it'can be assumed that additional efforts on the part of Agreement
{O V
t States for development of compliance programs would be no more than 0.25 FTE per State or approximately $725,000 (29 States x 0.25 FTE/ State x 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> /FTE x $50/hr = $725,000). NRC would continue its evaluation of Agreement State programs for adequacy and compatibility.
I 4 .The NRC is in the process of revising its compatibility' policy and has issued ~a proposed policy for. public comment (59 FR 37269; July 21,1994).
Although, the compatibility policy has not yet been finalized, the NRC p anticipates that a similar level of Agreement State compatibility will be il required for air emissions under the new Policy as is required under a
( )) Division Level'2 designation.
25 ;
l l
.J
I s
G Costs for Alternative 3 are summarized below:
Annual Expenditures __ FTE costs i
L NRC and Agreement State Licensees 0.12 $12k NRC and Agreement State Governments 0.24 24k ,
TOTALS 0.36 $36k l 7
One Time Expenditures- FTE Costs:
e j NRC Rulemaking 0.5 $50k NRC' Inspection Procedures and Inspector Training V 0.5 50k
. NRC Regulatory Guidance Development 0.5 Fu
,~\ p]
, Agreement State Regulations' Development 7.25 725k
, EPA Subpart 1 Rescission Rulemaking 0.5 50k TOTALS 9.25 $925k 1
- 5. Decision Rationale l For the alternatives -analyzed, the level of protection afforded the public he'alth and safety is essentially the same. For each alternative, I acceptable. levels for.radionuclide air emissions are based on a dose of f
10 mrem.per year-TEDE to the maximally exposed member of the public. Under Alternatives 1 (dual regulation) and 2 (eliminate NRC regulation of air emissions), the EPA Subpart I dose standard would remain in effect. Under 26 e !
7
.e._ ,
Alternative'3.(constraint rule), NRC would enact a rule imposing a constraint
' dose of 10 ' mrem per year and EPA would rescind Subpart I. f
..The NRC believes'that, in amending the CAA 'in 1990 to specifically. l
- address the issue of duplicate regulation, Congress intended that- dual
- . regulatory oversight by EPA and NRC be eliminated if it could be done l effectively. . Alternative 1 (dual regulation) makes no significant effort to support a finding' required by the CAA, Section 112(d)(9), for the dual I f
! regulation to be rescinded. Alternatives 2 and 3 are intended to be 4 l responsive to the Congressional mandate to reduce duplicative regulations.
Alternative 2 achieves this goal by discontinuing NRC inspection and 2
enforcement of dose to members of the public from air emissions. Alternative !
l 3' achieves this goal by providing assurance that the NRC regulatory framework '
Ewill provide an ample margin of safety. This Alternative will support an EPA O finding to-that'effect, and thereby, support a subsequent rescission of !
i
' l"/ Subpart I. This decision can only be made by the EPA Administrator. Based on 3
discussions with the EPA st'aff, the framework of Alternative 3 represents the EPA preferred approach. Thh N '
EPA has historically identified two components of the finding of
- sufficiency. First, NRC and Agreement State licensees must be in compliance with the quantitative emission limits of Subpart I (i.e., 10 mrem per year, TEDE). Overall, this condition has been demonstrated by studies conducted by EPA (Ref. 1) and by the recent reports submitted for Subpart'I compliance to 7
EPA by licensees. The second component af a mdiM that the NRC's and Agreement States' compliance programs provide sufficient continued / assurance that emissions would remain below the Subpart I standard, thereby protecting n the public and environment with .an " ample margin of safety." Of the l alternatives, .only Alternative 3 would bel effective in achieving this second 27
a
{'s
\' d component. Alternative 1 has been determined by the EPA not to provide the regulatory framework necessary to make this finding.
For Alternative 3, that of imposing controls by regulation, the
.relatively straightforward rule contemplated has been estimated to require
-person-year of Federal Government effort (including development of the rule,
/ regulatory guidance, inspection guidance, inspector training and EPA j rescission of Subpart I). Assuming all twenty-nine Agreement States would process parallel rules, this effort has been estimated to require an additional 7.25 staff-years (0.25 staff-year per State). This lower level of l effort for rulemaking by an Agreement State has been assumed considering the precedent established by NRC's rulemaking.
The total cost of each option is summarized in the table below: l
,~<
! l
\ /
Option One Time Annual Costs Costs -
1 - No Action / Dual Regulation o $3,194,600 2 - Eliminate NRC Regulation of Air Emissions $44/,000 $3,119,600 -
3 - Constraint Rule and Rescission of Subpart I $925,000 $36,000 Based on the above discussion, it is determined that Alternative 3 represents the preferred approach. Although Alternative I would be acceptable from a public health and safety perspective, it would not eliminate dual regulation. Alternative 2 would also be acceptable from a public health and safety perspective but would be far more burdensome to licensees as it would [
not support a rescission by EPA of Subpart I.
a n
wfp $
28
__ .. . .. . . . . . - _ . - . - .. = - . . . . . - -
I' Implementation
[])
.k 6.
l No. impediments to implementation of the recommended alternative have been identified. The documents necessary to support a proposed rulemaking -
have been developed. The level of effort required for completing the g rulemaking has been estimated at 0.5 staff-years, over a. od.
The staff prepark
/
atory guidanc further clarif the.
applicability of the rule and w$$t providesguidance on acceptable me,thods for A
- demonstrating compliance and for evaluating and reporting elevated effluents should the constraint level be exceeded. For Agreement States, a 3-year' -
period is allowed from time of issuance of the final rule for the States to develop and implement compatible regulations.
s i
4 1
1 b
29
l References j
(~}
D
- 1. EPA 430-R-92-Oll, "NESHAPS Rulemaking on Nuclear Regulatory Commission !
and Agreement State Licensees Other than Nuclear Power Reactors,
. Background Information Document," U. S. Environmental Protection Agency, l November 1992 (available from Government Printing Office).
- 2. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials l Facilities," U. S. Nuclear Regulatory Commission, July 1993 (available 1 from Government Printing Office). l
- 3. Inspection Procedure 87102, " Maintaining Effluents from Materials !
Facilities as Low as is Reasonably Achievable (ALARA)," NRC Inspection Manual, issued November 10,1994 (available from the NRC Public Document Room). i 1
- 4. ICRP Publication 60, "1990 Recommendations of the International Commission on Radiological Protection," Annals of the ICRP, Volume 21, !
No.1-3, published for the International Commission on Radiological Protection by Pergamon Press, 1991.
- 5. ICRP Publication 64, " Protection from Potential Exposure: A Conceptual Framework," Annals of the ICRP, Volume 23, No.1, published for the International Commission on Radiological Protection by Pergamon Press, 1993.
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i ATTACHMENT 3 NOTIFICATION FOR CONGRESSIONAL REVIEW O
4 3
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4.
cP*%y Oe k . UNITED STATES
- g NUCLEAR REGULATORY COMMISSION p
- WASHINGTON, D.C. 205654Xct V- *****
Mr. Robert P. Murphy General Counsel General Accounting Office Room 7175 a h ng n, 20548
Dear Mr. Murphy:
Pursuant to Subtitle E of the Small Business Regulatory Enforceme Fairness /
Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NR is p /
submitting a final rule that will constrain air emissions from t C liccr.aJ #
licensees such that no member of the public will receive a dosegof 10 mrem in a year from such emissions. This action is expected to be the inal step in providing a basis under which the Environmental Protection Agency (EPA) can rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal Government and to p NRC licensees without any negative health and safety impact.
h We have determined that this rule is nnt a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule which is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Register.
Sincerely, i
John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis im \
/
l
'/ 'T Mr. Robert P. Murphy
( "/
General Counsel General Accounting Office Room 7175 441 G. St., NW, Washington, DC 20548
Dear Mr. Murphy:
Pursuant to Subtitle E of the~ Small Busineks'Kegulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is /
submitting a final rule that will constrain air emissions from NRC l icensees such that no member of the public will receive a dose of 10 mrem in a year from such emissions. This action is expected to be the final step in providing a basis under which the Environmental Protection Agency (EPA) can ;
rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide ,
Emissions from Facilities Licensed by the Nuclear Regulatory Commission and j Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will i result in a significant reduction in burden to the Federal Government and to l NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget, Enclosed is a copy of the final rule which is being transmitted to the Office (n)
."j of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Register.
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis DISTRIBUTION:
RPHEB R/F ,
EDO R/F OGC R/F TSpeis FCostanzi CGallagher LRiani To receive a copy of this document, indicate in the box: "C" = Copy without attach-
- nt/ enclosure "E" = Copy with attachment / enclosure "N" = No copy ,
.FICE RPHEB:DRA _
RPHEB:DRA j OGC l D:DRA ( h l D:RES I
//f 7 NAME CTRaddatz / % JEGlenn C/ L WJ0lmstead BMMorfH DLMorri son' llDATE 5 /9 /96 $~/1/96 / / /96 f//#/96 y/g/96 0FFICIAL RECORD COPY (RES File Code) RES
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.,,,.[jtM '1 UNITED STATES
.- [ j 2
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20estMio01 r p q s % ..... / .
.The Honorable Al Gore The President of the Senate S-212, The Capitol - - -
Washington, DC 20510
Dear Mr. President:
Pursuant to Subtitle E of the Small Business Regulatory. Enforcement Fairness i Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is /
submitting a final' rule that will constrain air emissions from NRC +!c=xd &# ,
licensees such that no member of the public will receive a dose of 10 mrem in a year from such emissions. This action is expected to be the final step in providing a basis under which the Environmental Protection Agency (EPA) can i rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide 4 Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will j result in a significant reduction in burden to the Federal Government and to NRC licensees without any negative health and safety impact. I i
n We have determined that this rule is not a " major rule" as defined in 5 U.S.C. )
(d i 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule which is being transmitted to the Office 1 of the Federal Register for publication. The Regulatory Flexibility '
' Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Reaister.
Sincerely,
.I John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis l
1 1 i
- 9) i I
l
.. l
... l
'The Honorable.Al Gore (AV
) The. President of the Senate S-212, The Capitol !
Washington,'DC 20510 .
1
Dear Mr. President:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness I Act of.1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is i submittir.;; a- final rule that will constrain air emissions from NRC ti==F._ -
licensees such that no member of the public will receive a dose of 10 mrem in ;
a year from such emissions. This action is expected to be the final step in l providing a basis under which the Environmental Protection Agency (EPA) can rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory Connission and Federal. Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal Government and to NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management i and Budget. l Enclosed is a copy of the final rule which is being transmitted to the Office i of the Federal Register for publication. The Regulatory Flexibility l Certification is included in the final rule. Also enclosed is a copy of the !
D. I Regulatory Analysis for this final rule that contains the NRC's cost-benefit i determinations. This final rule is scheduled to become effective concurrent O
with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice l of its effectiveness will be published in the Federal Register. l Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis l
DISTRIBUTION:
RPHEB R/F ED0 R/F 1 OGC R/F l TSpeis i FCostanzi l CGallagher LRiani To receive a copy of this document, indicate in the box: "C" = Copy without attach-
/ enclosure "E" = Copy with attachment / enclosure "N" = No copy n _
l ICE RPHEB:DRA. l RPHEB:DRA OGC D:DRA D:RES F l l E CTRaddatz /22.-. JEGlenn/ M WJ0lmstead- BMMorrn DLMorris[onf/
d *
.lDATE 5 /q /96 6'/*t/96 " ' / /96 (/g /96 (/fo/96 0FFICIAL RECORD COPY l (RES File Code) RES ]
l l
a u - a a J N "'E69
- /; . &- UNITED STATES g g NUCLEAR REGULATORY COMMISSION
)
-f~g wAsHsworow. o.c. sones coot (m f% . . . . . /g s
The Honorable. Newt Gingrich The Speaker H-209, The Capitol- _ . .
i
~ Washington, DC 20515
Dear Mr. Speaker:
l Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness [
Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule that will constrain air emissions from NRC h
licensees such that no member of the public will receive a dose of 10 mrem in a' year from such emissions. This action is expected to be the final step in i providing a basis under which the Environmental Protection Agency (EPA) can l rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide 1 Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will result in a significant reduction in burden to the Federal Government and to NRC licensees without any negative health and safety impact. l
)
f-~s We have determined that this rule is not a " major rule" as defined in 5 U.S.C. I 804(2). We have confirmed this determination with the Office of Management (V i and Budget.
Enclosed is a copy of the final rule which is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective concurrent with the effective date of EPA's rescission of 40 CFR 61, Subpart I. A notice >
of its effectiveness will be published in the Federal Register.
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis f~y ;
l V )'
I
O The Honorable Newt Gingrich The Speaker V) l H-209, The Capitol Washington, DC 20515
Dear Mr. Speaker:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of.1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is /
submitting a final rule that will constrain air emissions from NRC Med y ..
licensees such that no member of the public will receive a dose of 10 mrem in a year from such emissions. This action is expected to be the final step in providing a basis under which the Environmental Protection Agency (EPA) can rescind 40 CFR 61, Subpart I " National Emission Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." Rescission of Subpart I will
. result in a significant reduction in burden to the Federal Government and to NRC licensees without any negative health and safety impact.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
l 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule which is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility l Certification is included in the final rule. Also enclosed is a copy of the
,n Regulatory Analysis for this final rule that contains the NRC's cost-benefit
( determinations. This final rule is scheduled to become effective concurrent v
) with the effective date of EPA's rescission of' 40 CFR 61, Subpart I. A notice of its effectiveness will be published in the Federal Register.
Sincerely, John C. Hoyle Secretary of the Commission
Enclosures:
Final Rule Regulatory Analysis DISTRIBUTION:
RPHEB R/F EDO R/F OGC R/F TSpeis FCostanzi CGallagher LRiani To receive a copy of this document, indicate in the box: "C" = Copy without attach-ment / enclosure "E" = Copy with attachment / enclosure "N" = No copy a FICE RPHEB:DRA RPHEB:DRA_ / OGC D:DRA ( M D:RES ///
_ ME CTRaddatz (V__. JEGlenn (7 p v WJ0lmstead BMMorrfs~ DLMorriTori
.lDATE 5/q/96 .f/1/96 -/ /96 6/lo/96 g7y,/96 0FFICIAL REDRD COPY (RES File Code) RES
' 's DOJ M/\
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, e/u/f6 1
i 4
i 3
1 i
j ATTACHMENT 4 i
! ENVIRONMENTAL ASSESSMENT l
s 1
3 4
5 i
l i
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1 1
l
s
/N Environmental Assessment and Finding of ij '
No Significant Impact on Proposed Rule on " Constraint For Dose to Individual Members of the Publi M I. THE ACTION
- w. Y s The action is a final rule to amend 10 CFR Part 20 to include a constraint for dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than power r actors. Most of the provisions of this rule were previously inspected against nd reported to the Environmental Protection Agency (EPA), under an agreement with EPA. This
(~% action will provide assurance to the EPA that future emissions from NRC
(
U) licensees will not exceed levels that will provide an ample margin of safety.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR Part 61 " National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than power reactors,' thereby relieving these NRC licensees from unnecessary dual regulations.
EPA previously proposed rescission of Subpart I for power reactors based on requirements contained in 10 CFR 50, Appendix I and a history of over , /
20 years of reported air emissions from power reactors resulting in doses well V below 10 mrem to the maximally exposed member of the public. W /
-m -, M d it finalized
[ } L M "% ndependenthe rescission of Subpart I for power reactors ""h of this rulemaking. #
v
)
l 4
l
.O l i II. THE NEED FOR THE RULEMAKING ACTION
'n.)
Subpart I currently limits dosho members of the public from air emissions of radionuclides from all NRC licensees except licensees possessing only sealed sources and uranium mill tailings piles disposed of in accordance with 40 CFR Part 192. Subpart I was promulgated to implement the Clean Air Act (CAA). The standard in Subpart I is that emissions of radionuclides to the ambient air from a facility regulated under this subpart shall not exceed
~
those amounts that would cause any member of the public to receive in any year an effective dose equivalent of 10 mrem /yr.
NRC licensees subject to Subpart I are also subject to NRC dose limits for members of the public contained in 10 CFR Part 20, Subpart D, entitled
" Radiation Dose Limits for Individual Members of the Public" ::,,, G,
/N Under Subpart D, licensees shall ensure that doses to members of the public k )
'/ are less than 100 mrem /yr from all pathways (including air emissions) and all sources associated with the licensee's operation. In addition, doses to members of the public must be as low as is reasonably achievable (ALARA).
Based on studies conducted by EPA and licensee reporting of doses to member [
of the public from air emissions, it is evident that mrem /yr to the maximally exposed member of the public from air emissions is reasonably achievable. Therefore, EPA's Subpart I represents duplicate dose regulation for affected licensees.
The NRC is establishing a constraint for dose to members of the public !
from air emissions of radionuclides of 10 mrem /yr total effective dose equivalent (TEDE). This action is necessary to provide a sufficient basis im
/ \
V 2
L l
upon which EPA can rescind Subpart I for NRC licensees other than power b reactors.
t- To ensure that Federal regulations are not excessively burdensome on the regulated community and most efficiently use government and licensee I resources, NRC and EPA are coordinating rulemakings. The effect of these rulemakings is to vest NRC with the principal responsibility for ensuring that l the health and safety of the public are protected from the potentially harmful effects of airborne emissions of radionuclides from NRC licensed facilities.
!!I. ALTERNATIVES TO THE RULEMAKING ACTION As required by 5102(2)(E) of NEPA (42 USC 4322(2)(E)), alternatives to the action have been considered. Three alternatives were considered.
.bs Alternative 1 - No Action l Alternative 1 maintains the status quo which involves licensees / ,
demonstrating compliance with the limits in Part 20 for dosho members of the public, including the ALARA requirement, and with the limits in 40 CFR Part 61 for dosho members of the public from air emissions of radionuclides. EPA. #
has determined that it will not rescind Subpart I for NRC licensees other than power reactors without a codified or otherwise enforceable dose value not to exceed 10 mrem /yr. The impact of this action would be the continued inefficient use of. licensee, NRC, EPA, and State resources, less confidence in ;
the NRC program to protect the health and safety of the public, and disregard of congressional requirements to avoid duplicative regulation through interagency cooperation.
.X .
S
,O Alternative 2 - Rulemaking i
Under alternative 2, the NRC would amend the current regulations in 10 CFR Part 20 to include a section on constraints for dos o members of the - - - -
public. A codified or otherwise enforceable dose value is an EPA condition for rescission of Subpart I. The impact of this alternative is that licensees /
would be subject to only one regulatory program for the control of'dosho '
members of the public and effluent release. Licensces would therefore need only calculate dosho members of the public against a single set of criteria -
- which are risk based and use a common dosimetry. Failure to report a dose in excess of the constraint level or failure to take prompt corrective actions would result in a notice of violation. Licensees and the public will have a
/
better understanding of how the Federal Government expects 44ve* the health and -
safety of the public and the environment will be protected from activities that could lead to radiation exposure.
v Alternative 3 - License Amendments Under alternative 3, the NRC would examine each lic issued ndef' 10.CFR Parts 30, 40, 50 excludingpowerreactors,60,72fjlos licensed for e possession of sealed sources only, to determine if robability existed that the licensee would have air emissions grea than a specified value (e.g.,
/
. 10 percent of the constraint value r a dose of 1 mrem /yr) and impoh --- - -
individual conditions on e c sucAicenseetoconstraindoshomembersof the public from air ission ' o less than 10 mrem /yr. The impact on
(
licensees f this-alt native would be similar to that of alternative,2.
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The impact on NRC would be signif housand licenses
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1 1 would have to be reviewed each year in conjunction with renewal or amendments l V' 'as well as new applications to ensure that any licensee who might exceed the I I
constraint would be required to report as a condition of the individual !
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license. !
l IV. ENVIRONMENTAL' IMPACTS OF THE ACTION The ' Commission has' examined the current regulatory framework for-controlling doho members of the public to ascertain the appropriate - --
regulatory. path to take that would continue to assure the level of protection currently afforded under the duplicative regulations while minimizing the burden on licensees and the government. There are no adverse impacts associated with this rule as air emissions would continue to be constrained at the same level as exists today.
jQ V. FINDING OF NO SIGNIFICANT IMPACT
. l l
The Commission has determined-under the National Environmental Policy J I
Act of 1969, as amended,-and the Commission's regulations in 10 CFR Part 51, that.the amendment to 10 CFR Part 20 will not have a significant impact on the quality of the human environment and that an environmental impact statement is i not required. This determination is based on the foregoing environmental assessment' performed in accordance with the procedures and criteria in Part 51
$ " Environmental Protection Regulations for Domestic Licensing and Related Regul atory . Function,"
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r VI. ' PERSONS CONTACTED:- !
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Tim Backstrom,-EPA,-OGC' y
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i' The draft rule language has been discussed with the Agreement States. A l 4
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, draft of the package was provided to them on April 18, 1995.
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_i ATTACHMENT 6 CONGRESSIONAL LETTERS 4
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f* "%e p* t UNITED STATES
" E NUCLEAR REGULATORY COMMISSION i
/ WASHINGTON, D.C. 206twe001 k [ .....
The Honorable. Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear safaty.
Committee on Environment and Public Works
. United States Senate
. Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Register. This final
-rulemaking amends NRC regulations to constrain dose to members of the public
-from air emissions of radioactive materials from NRC licensed facilities other than power reactors.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than power reactors, thereby relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on 7
i requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees 8
will not exceed levels that provide an ample margin of safety.
Sincerely, gg Dennis K. Rathbun, Director T**# J Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham
~
? .
i j 9 The Honorable Lauch Faircloth, Chairman
\" / ' Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety
. Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of' final rulemaking to be published in the Federal Reaister. This final
- rulemaking amends NRC regulations to constrain dose to members of the public from air emissions of radioactive materials from NRC licensed facilities other than power. reactors.
This action is expected to be the final step i's providing EPA with a basis-upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air P_ollutants," Subpart I.as it applies to NRC licensed facilities other than ,
, power reactors, thereby relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based.on requirements contained in 10.CFR Part 50, Appendix I, and a history of over 20 years of_ reported air emissions from power reactors resulting in doses well.
below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that provide an ample margin of safety.
-/,m\ Sincerely, V
Dennis K. Rathbun, Director Office of Congressional Affairs i
Enclosure:
Federal Register Notice-cc: Senator Bob Graham Distribution:
RPHEB R/F EDO R/F.
TSpeis NCostanzi'
- CGall agher -
LBRiani g locument Name: [a:\ congress.ltr]
- t. - . . % m . m:e.c , - .n - -. c.c ..n ,m w. v.w..,
b OFFICE RPHEB:DRA RPHEB:DRV D:DRA:ROL D:RES M D:OCA NAME- CTRaddat "JEGlenMfj/ BMMorri DMorrison DKRathbun DATE' 5/k98 5/1/98 5/Je/98 5 fi98 ' / /98 OFFICIAL RECORD COPY
l
, p3 ct: l d
4 UNITED STATES '
O NUCLEAR REGULATORY COMMISSION '
WASHINGTON, D.C. 2000tL4001 A
v j% . .... l \
i The Honorable Dan Schaefer, Chairman I Subcommittee on' Energy and Power Committee on Commerce -
United States House of Representatives Washington, DC 20515 ,
l
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Register. This final j rulemaking amends NRC regulations to constrain dose to members of the public l
'from air emissions of radioactive materials from NRC licensed facilities other than power reactors.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than power reactors, thereby relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on '
Q requirements contained in 10 CFR Fart 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well Ljt below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees will not exceed levels that provide an ample margin of safety.
Sincerely, ;
I Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: . Representative Frank Pallone ,
l i
/ N (m) 1 4 - , -
r . _ . _ .
,.y
- h* .
f~']; The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power -
's Committee on Commerce 4 United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a notice of final rulemaking to be published in the Federal Register. This final ,
rulemaking amends NRC regulations to constrain dose to members of the public from-air emissions of radioactive materials from NRC licensed facilities other than power reactors.
This action is expected to be the final step in providing EPA with a basis upon which to rescind 40 CFR 61 " National Emission Standards for Hazardous Air Pollutants," Subpart I as it applies to NRC licensed facilities other than power reactors, thereby relieving these NRC licensees from unnecessary dual regulations. EPA has already rescinded Subpart I for power reactors based on requirements contained in 10 CFR Part 50, Appendix I, and a history of over 20 years of reported air emissions from power reactors resulting in doses well below 10 mrem /yr to the maximally exposed member of the public. This action will provide assurance to the EPA that future emissions from NRC licensees will' not exceed levels that provide an ample margin of safety.
,_s Sincerely, I l L.,/
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice _ ..
cc: Representative Frank Pallone Distribution:
RPHEB R/F EDO R/F TSpets NCostanzi CGallagher LBRiani r Document Name: [a:\ congress.ltr] f pt i
- t. - . .m .e m - m.i. a m. we c . cm m .n-i.n w. c . cm m .n-i.,.w. u . u.
'^ OFFICE RPHEB:DRA RPHEB:DRA D:DRA:REJfL D:RES NA D:OCA
) NAME CTRaddatz @ JEGlennIh BMMorris 1 DMorrbn! DKRathbun
_DATE 5/I/98 5/ f8
/9 5// P/98 5 //#98 / /96 OFFICIAL RECORD COPY
/